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Vitamin D in Minorities With Prediabetes

Primary Purpose

Pre-diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

vitamin D

placebo

About this trial

This is an interventional prevention trial for Pre-diabetes focused on measuring pre-diabetes, minorities, oral glucose tolerance test, disposition index, insulin secretion, insulin sensitivity, diabetes

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age greater than 40.
Impaired fasting glucose (FPG level greater than 100 and less than 126 mg/dl); and/or
Impaired glucose tolerance (2-h plasma glucose concentration after 75 gram glucose load greater than 140 and less than 200 mg/dl)
Serum 25-OHD less than 30 ng/ml
Able and willing to provide informed consent

Exclusion Criteria:

FPG greater than 126 mg/dl or 2-hour-OGTT plasma glucose greater than 200 mg/dl
Major psychiatric disorder on medication (excluding successfully treated depression)
Diagnosed diabetes mellitus
HIV/AIDS
Major hematological, hepatic (AST/ALT levels greater than or equal to 2 times normal) or renal eGFR less than 60 ml/min) disorder
History of carcinoma, except skin basal cell or squamous cell skin carcinomas
Heart failure, unstable angina or history of a myocardial infarction
Alcohol or substance abuse
Current treatment with glucocorticoids
Current treatment with diabetes medications, including metformin
Cushing's syndrome
Primary hyperparathyroidism
Nephrolithiasis
Pregnancy or breast-feeding
Regular visits to a tanning salon (unlikely in this minority population)

Sites / Locations

Charles Drew University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

vitamin D

Arm Description

Subjects with low vitamin D levels and pre-diabetes

Outcomes

Primary Outcome Measures

Percent of Subjects Who Develop Diabetes

Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl

Secondary Outcome Measures

Disposition Index

Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better

Full Information

NCT ID

NCT00876928

First Posted

April 6, 2009

Last Updated

April 17, 2013

Sponsor

Charles Drew University of Medicine and Science

Collaborators

American Diabetes Association

1. Study Identification

Unique Protocol Identification Number

NCT00876928

Brief Title

Vitamin D in Minorities With Prediabetes

Official Title

Effect of Vitamin D Supplementation on Pre-Diabetes in a Minority Population

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charles Drew University of Medicine and Science

Collaborators

American Diabetes Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-diabetes

Keywords

pre-diabetes, minorities, oral glucose tolerance test, disposition index, insulin secretion, insulin sensitivity, diabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Subjects with low vitamin D levels and pre-diabetes

Arm Title

vitamin D

Arm Type

Experimental

Arm Description

Subjects with low vitamin D levels and pre-diabetes

Intervention Type

Drug

Intervention Name(s)

vitamin D

Intervention Description

liquid vitamin D3 dissolved in medium chain triglyceride once a week

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

medium chain triglyceride given once per week

Primary Outcome Measure Information:

Title

Percent of Subjects Who Develop Diabetes

Description

Diabetes defined by a FPG>=126 mg/dl or a 2-hr glucose concentration on an OGTT of >=200 mg/dl

Time Frame

one year

Secondary Outcome Measure Information:

Title

Disposition Index

Description

Measure of insulin secretion multiplied by measure of insulin sensitivity,both derived from oral glucose tolerance test; higher values are better

Time Frame

Baseline, 3, 6, 9, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mayer B. Davidson, MD

Organizational Affiliation

Charles Drew University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charles Drew University

City

Los Angeles

State/Province

California

ZIP/Postal Code

90059

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25011019

Citation

Sinha-Hikim I, Duran P, Shen R, Lee M, Friedman TC, Davidson MB. Effect of long term vitamin D supplementation on biomarkers of inflammation in Latino and African-American subjects with pre-diabetes and hypovitaminosis D. Horm Metab Res. 2015 Apr;47(4):280-3. doi: 10.1055/s-0034-1383652. Epub 2014 Jul 10.

Results Reference

derived

PubMed Identifier

23033239

Citation

Davidson MB, Duran P, Lee ML, Friedman TC. High-dose vitamin D supplementation in people with prediabetes and hypovitaminosis D. Diabetes Care. 2013 Feb;36(2):260-6. doi: 10.2337/dc12-1204. Epub 2012 Oct 1.

Results Reference

derived

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Vitamin D in Minorities With Prediabetes

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