The Influence of Treatment Modality and E t h n i c ity on Attitudes in Type 2 Diabetes

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E p i d e m i o l o g y / H e a l t h S e r v i c e s / P s y c h o s o c i a l R e s e a r c h O R I G I N A L A R T I C L E The Influence of Treatment Modality and E t h n i c ity on Attitudes in Type 2 Diabetes JAMES T. FITZGERALD, PHD LARRY D. GRUPPEN, PHD ROBERT M. ANDERSON, EDD MARTHA M. FUNNELL, MS, RN, CDE O B J E C T I V E The study examines diabetes attitude diff e rences by treatment modality (insulin vs. no insulin), race/ethnicity, and the interaction of these two variables for people with type 2 diabetes. RESEARCH DESIGN AND METHODS Data were collected with the Diabetes Care P rofile (DCP), an instrument that assesses psychosocial factors related to diabetes. Part i c i p a n t s (n = 672) were re c ruited in the metropolitan Detroit, Michigan, area from 1993 to 1996. A total of 68% of these participants were African-Americans with type 2 diabetes, and 32% were Caucasians with type 2 diabetes. Analyses of covariance were perf o rmed to examine the effects of r a c e / e t h n i c i t y, treatment, and their interaction for each DCP scale. R E S U LT S The four patient categories (two ethnicities by two treatment modalities) diff e red by age, years with diabetes, education, and sex distribution. Treatment modality had a significant effect on 6 of the 16 DCP scales (Control, Social and Personal Factors, Positive Attitude, Negative Attitude, Self-Care Ability, and Exercise Barriers). Ethnicity was a significant e ffect for three scales (Control, Support, and Support Attitudes). The interaction of race/ethnicity and treatment modality was a significant effect for two related attitude scales (Positive Attitude and Negative Attitude). C O N C L U S I O N S The results suggest that attitudes toward diabetes are similar for African-American and Caucasian patients with type 2 diabetes. The results also suggest that t reatment modality has a greater effect on attitudes than either race/ethnicity or the interaction e ffect. However, Caucasian patients using insulin diff e red from the other patient groups by having the least positive and the most negative attitudes re g a rding diabetes. Diabetes is a serious disease in the U.S. population and is more prevalent in older adults and in minorities. Fort u- n a t e l y, many complications from diabetes can be avoided or delayed with pro p e r management. Diabetes is foremost a selfmanaged disease; treatment and pre v e n t i o n of acute and long-term complications are l a rgely a function of the patient s decisions on a daily basis. Because patients deliver SCOTT J. JACOBER, DO GEORGE GRUNBERGER, MD LINDA C. AMAN, MSN, RN, CS, CDE Diabetes Care 2 3 :3 1 3 318, 2000 most of their own diabetes care, understanding the factors that affect self-management behavior is important, including health attitudes and treatment modality. The relationship of patient attitudes and patient behavior has been central in both the health belief model (1) and in the theory of re a- soned action (2). Several studies have also demonstrated the importance of patients attitudes and beliefs on health behavior. F rom the Department of Medical Education ( J. T. F., L.D.G., R.M.A.) and the Michigan Diabetes Research and Training Center (M.M.F.), the University of Michigan Medical School, Ann Arbor; the Department of Internal Medicine (S.J.J., G.G.), Wayne State University School of Medicine, Detroit; and Diabetes Services (L.C.A.), Oakwood Healthcare, Inc., Dearborn, Michigan. A d d ress correspondence and reprint requests to James T. Fitzgerald, PhD, Department of Medical Education, the University of Michigan Medical School, the Towsley Center, Room 1114, Box 0201, Ann Arbor, MI 48109-0201. E-mail: tfitz@umich.edu. Received for publication 13 July 1999 and accepted in revised form 17 November 1999. A b b re v i a t i o n s : D C P, Diabetes Care Pro f i l e. A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. M c C o rd and Brandenburg (1) found that type 2 patients described as noncompliant w e re more likely to believe that diabetes would not affect their life outcomes. The p a t i e n t s confidence in modern medicine has been found to be a factor in patient response to treatment re c o m m e n d a t i o n s (2,3). Several studies have investigated factors that influence patient attitudes. Dietrich (4) interviewed seven type 2 diabetic patients and suggested that physician attitude at the time of diagnosis was critical in patients attitudes about the seriousness of diabetes and patients subsequent self-management behavior. Similarly, Hunt et al. (5) found that patient attitudes toward insulin therapy were influenced by a patient s interaction with health professionals as well as personal experience and observ a t i o n. Patient beliefs, attitudes, and behaviors a re influenced by cultural and socioeconomic factors (6). The relationship of cult u re to health beliefs, attitudes, and behavior is especially important in the t reatment of diabetes, which usually involves changing patterns of eating, physical activity, and other culturally embedded behaviors. If diabetes treatment re c o m- mendations are to be effective, then they must be sensitive and relevant to the cult u re of the people who are expected to c a rry them out (7). This study examines attitude diff e rences among tre a t m e n t modalities and ethnic groups. In two previous studies assessing the psychosocial factors related to diabetes for people with type 2 diabetes, we found that attitudes d i ff e red between patients using insulin and patients not using insulin (8) but not between African-American and Caucasian patients (9). In both studies, the Diabetes C a re Profile (DCP) was used to measure diabetes attitudes. The DCP is a valid and reliable instrument that assesses social and psychological factors related to diabetes and its treatment (10). In a study focusing on the appropriateness of the DCP for the African-American population with diabetes, a two-way analysis of variance for each scale suggested that the use of insulin in the treatment of diabetes had a gre a t e r e ffect on patient attitudes than ethnic b a c k g round did (9). Furt h e rm o re, the results of several scales indicated a signifi- DIABETES CARE, VOLUME 23, NUMBER 3, MARCH 2000 313

Diabetes treatment, race/ethnicity, and attitudes Table 1 Scoring and sample items for the Diabetes Care Profile scales S c o r i n g Diabetes Care Profile scale G o o d P o o r Items (n) Sample item C o n t rol 1 5 19 During the past year, how often have you had changes in your blood sugar (too high) because you were sick or had an infection? Social and Personal Factors 1 5 13 How often has your diabetes kept you from doing your normal daily activities during the past year? Positive Attitude 5 1 5 I feel satisfied with my life. Negative Attitude 1 5 6 I am afraid of my diabetes. S e l f - C a re Ability 5 1 4 I am able to keep my blood sugar in good contro l. I m p o rtance of Care 5 1 4 I think it is important for me to keep my blood sugar in good contro l. S e l f - C a re Adhere n c e 5 1 4 I keep my blood sugar in good contro l. Diet Adhere n c e 5 1 4 (If told to diet) How often do you follow a meal plan or diet? Medical Barr i e r s 1 5 8 How often do you change the timing and/or dose of your insulin or diabetes pills because you missed an earlier dose? E x e rcise Barr i e r s 1 5 5 How often do you have trouble getting enough exercise because you are too busy? Monitoring Barr i e r s 1 5 11 When you don t test for sugar as often as you have been told, how often is it because you forg o t? Understanding Management Practice 5 1 10 How do you rate your understanding of diet and blood sugar contro l? L o n g - Te rm Care Benefits 5 1 5 Taking the best possible care of diabetes will delay or prevent eye pro b l e m s. S u p p o rt Needs 5 1 * 6 I want a lot of help and support from my family and friends in following my meal plan. S u p p o rt 5 1 6 My family and friends help and support me a lot to follow my meal plan. S u p p o rt Attitudes 5 1 6 My family and friends accept me and my diabetes. *No pre f e rred score exists for the Support Needs scale because the scale is an assessment (5 = needing more support and 1 = needing less support ). cant interaction effect between insulin use and race/ethnicity (i.e., the joint effect of insulin use and race/ethnicity had a significant influence on several scales). However, that study did not control for demographic d i ff e rences between the diff e rent ethnic g roups. In another study, we compare d quality-of-life measures for patients with diabetes. In that study, insulin use was also found to have a significant negative influence on several scales of the DCP (8). U n f o rt u n a t e l y, this study included few non-caucasians, which prevented comparisons by race/ethnicity. The present study addresses a question that arose from the two pre c e d i n g studies: What is the influence of race/ethn i c i t y, treatment modality, and their interaction (i.e., the joint effect of race/ethnicity and treatment modality) on the attitudes of patients with type 2 diabetes? Our pre v i- ous studies did not specifically examine the influence of race/ethnicity and tre a t- ment modality on diabetes attitudes and c e rtainly not did control for possible intervening factors. This study focuses on these likely attitudinal influences by asking the following re s e a rch question: Do attitudes t o w a rd diabetes as measured by the 16 scales of the DCP differ by diabetes tre a t- ment modality and race/ethnicity? RESEARCH DESIGN AND M E T H O D S The DCP Data were collected using the DCP, which is an instrument that assesses social and psychological factors related to diabetes and its t reatment (10). The DCP is a self-administ e red questionnaire specific to diabetes. The i n s t rument has 234 items in seven sections and includes questions concerning demographic information and self-care practices. The questionnaire can be completed in 30 40 min. A total of 16 DCP scales assess an individual s diabetes attitudes (e.g., the Positive Attitude and the Support Attitudes scales), diabetes beliefs (e.g., the Import a n c e of Care and the Long-Te rm Care Benefits scales), re p o rted diabetes self-management b a rriers (e.g., the Self-Care Adherence and the Diet Adherence scales), and the diff i c u l- ties of diabetes self-management (e.g., the Medical Barriers and the Exercise Barr i e r s scales). A sample item from each scale, the scoring ranges, the interpretation of the end points, and the number of items for 16 DCP scales are provided in Table 1. Sample P a rticipants were re c ruited from six locations in the metropolitan Detroit, Michigan, a rea: a suburban endocrinology clinic, two urban endocrinology clinics, an urban diabetes clinic, a suburban private practice, and an urban diabetes educational program (n = 771). Data were collected fro m June 1993 to January 1996. While waiting for scheduled appointments, adult clinic patients were asked whether they had diabetes. Those patients with diabetes were asked to complete the DCP. The overall response rate was 66%; among the six sites, the rates ranged from 56 to 79%. For this s t u d y, the sample was limited to patients who indicated that they were either African-American or Caucasian and had type 2 diabetes (n = 672). Statistical methods P e a r s o n s 2 was used to determine diff e r- ences in sex distribution and education level among the four patient groups: African- Americans using insulin, African-Americans not using insulin, Caucasians using insulin, and Caucasians not using insulin. Diff e r- ences in age and years with diabetes were d e t e rmined between treatment modality and ethnic group by analysis of variance. To determine whether scale scores diff e red among the six re c ruitment sites, an analysis of variance was perf o rmed for each scale with a Bonferroni adjustment for mul- 314 DIABETES CARE, VOLUME 23, NUMBER 3, MARCH 2000

Fitzgerald and Associates Table 2 Demographics of participants with type 2 diabetes by race/ethnicity and treatment modality A f r i c a n - A m e r i c a n s C a u c a s i a n s N o t N o t Using insulin using insulin Using insulin using insulin P n 246 211 103 112 Wo m e n 138 (60) 119 (59) 65 (66) 49 (47) 0. 04 Age (years) 61.9 ± 12.3 (20 84) 61.4 ± 11.8 (16 84) 63.2 ± 14.7 (18 87) 66.1 ± 10.2 (37 88) 0. 01 * Years since diagnosis 14.3 ± 9.5 9.1 ± 7.5 15.8 ± 8.5 10.6 ± 8.8 0. 01 Years of formal education 8 21 22 21 13 0. 04 9 11 21 25 13 21 12 28 28 33 41 13 15 23 14 21 15 16 7 11 12 10 Data are n, n (%), means ± SD (ranges), or %. *Caucasians not using insulin diff e red from both African-American groups; participants not using insulin diff e red fro m p a rticipants using insulin. tiple statistical tests (P = 0.003). Site scale s c o res were examined within race/ethnicity (African-American and Caucasian) and t reatment modality (using insulin and not using insulin). Analyses of covariance were perf o rm e d to examine the effects of race/ethnicity (African-American and Caucasian), tre a t- ment modality (using insulin and not using insulin), and the interaction of race/ethnicity and treatment modality for each DCP scale. In this study, the analysis of covariance controlled for the covariates of age, years with diabetes, years of formal education, and sex distribution. The subgro u p s d i ff e red substantially re g a rding these characteristics. Thus, the DCP scale score s re q u i red adjustment to make unbiased comparisons between treatment modalities and ethnic groups. When a significant interaction effect was indicated, a post hoc F test was perf o rmed with the adjusted means (P 0. 0 5 ). R E S U LT S Demographics The study population had an average age of 63 ± 12 years, and most participants were women (58%). A total of 68% of the participants were African-American, and 32% w e re Caucasian. Of the participants, 52% w e re treating their diabetes with insulin. The four patient groups diff e red demographically (Table 2). In three of the four patient categories, most of the part i c i p a n t s w e re women. Caucasians not using insulin w e re significantly older than patients in the other patient categories. Patients using insulin had diabetes of a longer duration. F i n a l l y, the years of formal education were d i ff e rent among the patient categories. Insulin users were more likely to have a higher level of education ( 13 years) than patients not using insulin. Caucasians also had more years of formal education than A f r i c a n - A m e r i c a n s. Although participants were re c ru i t e d f rom six sites, no statistically significant d i ff e rence was indicated for any of the 16 DCP scales by site within treatment modality and race/ethnicity. Effects of race/ethnicity, diabetes treatment modality, and their interaction Table 3 presents a summary of the analysis of covariance for each DCP scale. These analyses focused on the main effects of r a c e / e t h n i c i t y, treatment modality, and their interaction while controlling for sex, age, years with diabetes, and education. The Adjusted Means column in Table 3 pro v i d e s the scale means for each patient group after c o n t rolling for sex, age, years with diabetes, and education. The R 2 column provides a m e a s u re of the amount of variance explained by the analysis of covariance model (i.e., the amount of variance by r a c e / e t h n i c i t y, treatment modality, and their interaction). The Source of Variation column indicates the three sources of variation within the model (race/ethnicity, tre a t m e n t m o d a l i t y, and their interaction) and whether each source had a significant effect on the scale (as determined by the P value). Ethnicity and treatment modality are re f e rred to as the main effects of the model, and the interaction effect refers to the interaction of race/ethnicity and treatment modality. To better explain Table 3, we describe the results for the Control scale in more detail. The Control adjusted means show that African-Americans not using insulin had the fewest control problems (1.81) followed by Caucasians not using insulin (1.89) and African-Americans using insulin (1.92). Caucasians using insulin had the most control problems (2.14). The R 2 c o l- umn indicates that race/ethnicity, tre a t m e n t m o d a l i t y, and their interaction can explain 15% of the variance in the Control scale. Both race/ethnicity (P = 0.032) and tre a t- ment modality (P = 0.014) were significant in explaining the variance in the Contro l scale. The interaction effect did not have a significant influence. Treatment modality was a significant main effect for the Social and Personal Factors scale, the Self-Care Ability scale, and the Exercise Barriers scale. Ethnicity was the only significant main effect for the Supp o rt scale and the Support Attitudes scale. For both the Positive Attitude scale and the Negative Attitude scale, treatment modality and the interaction of race/ethnicity and t reatment were significant effects. For the remaining scales, no significant main or interaction effects were evident. Post hoc tests for the Positive Attitude and Negative Attitude scales The interaction of race/ethnicity and tre a t- ment was a significant effect for both the Positive Attitude and the Negative Attitude scales. For the Positive Attitude scale, post hoc tests indicated that Caucasians using insulin had lower scores than African-Americans using insulin and Caucasians not using DIABETES CARE, VOLUME 23, NUMBER 3, MARCH 2000 315

Diabetes treatment, race/ethnicity, and attitudes Table 3 Analysis of covariance of the Diabetes Care Profile scales Treatment (adjusted means) Significance of source of variation (P) I n s u l i n N o Ethnicity and S c a l e u s i n g i n s u l i n E t h n i c i t y Tre a t m e n t t re a t m e n t R 2 (P) C o n t ro l A f r i c a n - A m e r i c a n s 1. 92 1. 81 0. 032 0. 014 0. 324 0.15 ( 0. 001 ) C a u c a s i a n s 2. 14 1. 89 Social and Personal Factors A f r i c a n - A m e r i c a n s 2. 60 2. 41 0. 871 0. 001 0. 267 0.12 ( 0. 001 ) C a u c a s i a n s 2. 67 2. 32 Positive Attitude A f r i c a n - A m e r i c a n s 3. 15 3. 11 0. 940 0. 035 0. 006 0.03 (0.008) C a u c a s i a n s 2. 95 3. 30 Negative Attitude A f r i c a n - A m e r i c a n s 2. 49 2. 39 0. 308 0. 001 0. 033 0.08 ( 0. 001 ) C a u c a s i a n s 2. 72 2. 31 S e l f - C a re Ability A f r i c a n - A m e r i c a n s 3. 03 3. 22 0. 445 0. 001 0. 391 0.05 (0.001) C a u c a s i a n s 2. 91 3. 22 I m p o rtance of Care A f r i c a n - A m e r i c a n s 4. 35 4. 41 0. 501 0. 048 0. 241 0.01 (0.400) C a u c a s i a n s 4. 24 4. 44 S e l f - C a re Adhere n c e A f r i c a n - A m e r i c a n s 3. 24 3. 28 0. 420 0. 135 0. 297 0.03 (0.013) C a u c a s i a n s 3. 11 3. 30 Diet Adhere n c e A f r i c a n - A m e r i c a n s 2. 93 2. 85 0. 858 0. 311 0. 857 0.02 (0.350) C a u c a s i a n s 2. 93 2. 82 Medical Barr i e r s A f r i c a n - A m e r i c a n s 1. 34 1. 36 0. 986 0. 749 0. 471 0.05 (0.004) C a u c a s i a n s 1. 38 1. 32 E x e rcise Barr i e r s A f r i c a n - A m e r i c a n s 2. 11 1. 93 0. 164 0. 007 0. 442 0.07 ( 0. 001 ) C a u c a s i a n s 2. 29 1. 98 Monitoring Barr i e r s A f r i c a n - A m e r i c a n s 1. 53 1. 48 0. 219 0. 614 0. 831 0.04 (0.113) C a u c a s i a n s 1. 44 1. 42 Understanding Management Practice A f r i c a n - A m e r i c a n s 3. 37 3. 53 0. 975 0. 508 0. 267 0.08 ( 0. 001 ) C a u c a s i a n s 3. 47 3. 43 L o n g - Te rm Care Benefits A f r i c a n - A m e r i c a n s 4. 40 4. 30 0. 588 0. 916 0. 113 0.03 (0.028) C a u c a s i a n s 4. 25 4. 37 S u p p o rt Needs A f r i c a n - A m e r i c a n s 3. 54 3. 37 0. 391 0. 079 0. 711 0.04 (0.025) C a u c a s i a n s 3. 49 3. 23 S u p p o rt A f r i c a n - A m e r i c a n s 3. 79 3. 65 0. 003 0. 187 0. 937 0.03 (0.048) C a u c a s i a n s 3. 49 3. 36 S u p p o rt Attitudes A f r i c a n - A m e r i c a n s 3. 90 4. 02 0. 043 0. 080 0. 874 0.03 (0.015) C a u c a s i a n s 3. 79 3. 89 Data are adjusted means, P, or R 2 (P). Scale means were adjusted for the covariates. insulin (i.e., Caucasians using insulin were less positive about their diabetes than the other two patient groups). The post hoc tests for the Negative Attitude scale were s i m i l a r. Caucasians using insulin were more negative about their diabetes than both of the African-American patient groups and the Caucasians not using insulin. C O N C L U S I O N S Several study limitations must be considered when interp reting these results. First, this is a c ross-sectional study; the data cannot 316 DIABETES CARE, VOLUME 23, NUMBER 3, MARCH 2000

Fitzgerald and Associates a d d ress attitudinal changes within patients over time. A second limitation is the fact that the study re c ruited from six sites. Although we did not find diff e rences in the DCP scales among the sites, diff e rences may exist that were not identified in our analysis. F i n a l l y, the African-Americans and Caucasians with type 2 diabetes diff e red demog r a p h i c a l l y, which makes comparisons d i fficult. To address this diff i c u l t y, we chose to control for the diff e rences statistically. The analysis of covariance indicates that race/ethnicity, treatment modality, and their interaction did not have a significant influence on half of the DCP scales (8 out of 16). The scales where these factors were not influential were the Importance of C a re, Self-Care Adherence, Diet Adhere n c e, Medical Barriers, Monitoring Barr i e r s, Understanding Management Practice, L o n g - Te rm Care Benefits, and Support Needs. In other words, for these scales, African-Americans and Caucasians with diabetes do not score diff e rently; furt h e r- m o re, patients using insulin did not score d i ff e rently from patients not using insulin. For the other eight scales, one or more of the variables (race/ethnicity, tre a t m e n t m o d a l i t y, and their interaction) had a significant influence. Of the three variables, tre a t- ment modality influenced the most scales; t reatment modality was a significant influence for 6 of the 16 DCP scales (Contro l, Social and Personal Factors, Positive Attitude, Negative Attitude, Self-Care Ability, and Exercise Barriers). This suggests that patients using insulin have diff e rent attitudes and problems in these areas of their diabetes care from those of patients not using insulin. Ethnicity had a significant influence on only three scales (Control, Support, and S u p p o rt Attitude). However, two of these scales dealt with social support. In comparison with Caucasians, African-Americans re p o rted receiving more support from family and friends. Furt h e rm o re, the support they received was interpreted more posit i v e l y. Diff e rences between African-Americans and Caucasians in the area of social s u p p o rt have been noted elsewhere (11 15). The focus of this study centered on the joint effect of race/ethnicity and tre a t m e n t modality on diabetes attitudes. The results of the analyses indicated that the interaction of race/ethnicity and treatment modality was a significant effect for only two scales, Positive Attitude and Negative Attitude; however, these scales are related. The Positive Attitude and Negative Attitude scales provide two m e a s u res of patients overall attitudes toward their disease. Intere s t i n g l y, the biggest disparity occurred between the two Caucasian patient groups. The Caucasians not using insulin re p o rted the most positive attitude and the least negative attitude (adjusted means of 3.30 and 2.31, respectively). The reverse was true for the Caucasians using insulin: this group re p o rted the least positive attitude and the most negative attitude (adjusted means of 2.95 and 2.72, re s p e c- tively). On the other hand, African-Americans were less distinct in the scores for these attitude scales: the adjusted means for Positive Attitude were 3.15 for patients using insulin and 3.11 for those not using insulin, and for Negative Attitude, the adjusted means were 2.49 for patients using insulin and 2.39 for those not using insulin. These results suggest that insulin use has a significant effect on Caucasian patients overall positive and negative attitudes toward diabetes. This effect was not as apparent in African-American patients, but this does not mean that treatment type is not important to African-Americans. The type of diabetes treatment has a significant e ffect on the DCP scales concerning the social and personal life of the patient, the ability of the patient to provide self-management, and the perceived barriers to e x e rcise for all patients in this study. The diff e rences in the positive and negative attitudes of Caucasians using insulin suggest that diabetes and/or its treatment is p e rceived diff e rently by this patient gro u p. For these Caucasian patients, the use of insulin injections and the accompanying g reater emphasis on glucose testing may s t rengthen the perception of diabetes as a serious disease. African-Americans appear to have a more stable overall attitude toward diabetes that is not altered significantly with a change in treatment. However, the data p resented in the study are cro s s - s e c t i o n a l, and, as such, the study cannot dire c t l y a d d ress the attitudinal changes that may or may not have occurred among patients with the introduction of insulin. Diff e re n c e s among the patient groups may reflect an initial reaction to insulin, or the attitudes may have evolved gradually in response to any of several factors related to insulin use. The reason for the diff e rences in positive and negative attitude is unclear. Further investigation is needed in the area of patient perception of diabetes. Is the switch to insulin a pivotal moment in the diabetes c a re and education of Caucasians? What factors and conditions stimulate adjustments or shifts in perceptions and attitudes? How do these perceptions affect the willingness to take insulin and subsequent self-management behavior? Should diff e r- ent strategies be used for patients from diff e rent ethnic groups? These are import a n t questions to answer to better understand and work with patients. For care providers and diabetes educators, these results suggest that attitudes t o w a rd diabetes are similar for A f r i c a n - American and Caucasian patients with type 2 diabetes. However, for Caucasian patients using insulin, overall attitudes about diabetes need to be evaluated and addre s s e d. For the health re s e a rc h e r, this study emphasizes the necessity of contro l l i n g for differing demographics when comparing two samples. The use of an analysis of covariance was essential in controlling for variations in other demographic characteristics to better understand the re l a t i o n s h i p of race/ethnicity and treatment modality to d i a b e t e s - related attitudes. A c k n o w l e d g m e n t s This study was supp o rted in part by grant 5-P-60-DK-20572 fro m the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of H e a l t h. 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