Los Angeles, California 90059

  • Diabetes

Purpose:

Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.


Study summary:

Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.


Criteria:

Inclusion Criteria: 1. Age greater than 40. 2. Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or 3. Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl) 4. Serum 25-OHD less than 30 ng/ml 5. Able and willing to provide informed consent Exclusion Criteria: 1. FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl 2. Major psychiatric disorder on medication (excluding successfully treated depression) 3. Diagnosed diabetes mellitus 4. HIV/AIDS 5. Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder 6. History of carcinoma, except skin basal cell or squamous cell skin carcinomas 7. Heart failure, unstable angina or history of a myocardial infarction 8. Alcohol or substance abuse 9. Current treatment with glucocorticoids 10. Current treatment with diabetes medications, including metformin 11. Cushing's syndrome 12. Primary hyperparathyroidism 13. Nephrolithiasis 14. Pregnancy or breast-feeding 15. Regular visits to a tanning salon (unlikely in this minority population)


NCT ID:

NCT00876928


Primary Contact:

Principal Investigator
Mayer B. Davidson, MD
Charles Drew University

Mayer B. Davidson, MD
Phone: 323 357-3439
Email: mayerdavidson@cdrewu.edu


Backup Contact:

Email: petraduran@cdrewu.edu
Petra Duran, BS
Phone: 323 357-3428


Location Contact:

Los Angeles, California 90059
United States

Petra Duran, BS
Phone: 323-357-3428
Email: petraduran@cdrewu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 16, 2021

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