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This study will supplement African American male (AAM) veterans at risk for diabetes and newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps to improve early markers of diabetes. The study will be done at Veteran Administration Medical Center in Chicago.
The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and safety for improving early markers of T2DM in African American male (AAM) veterans at risk for T2DM (n=205, duration 12 months).
The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary outcomes will include various parameters of glucose metabolism and other biomarkers.
Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and 25OHD at the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | Placebo: One capsule weekly |
|
| Arm 2 | Experimental | 50K vitamin D2: One capsule weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oral Glucose Insulin Sensitivity (OGIS) | Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline at 12 Months | Baseline and 12 Months | |
| Insulin Sensitivity by Matsuda Composite | Insulin Sensitivity by Matsuda Composite - index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS. Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]. |
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Inclusion Criteria:
Veterans at Jesse Brown VA Medical Center (JBVAMC) only
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena I. Barengolts, MD | Jesse Brown VA Medical Center, Chicago, IL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26209747 | Derived | Ciubotaru I, Green SJ, Kukreja S, Barengolts E. Significant differences in fecal microbiota are associated with various stages of glucose tolerance in African American male veterans. Transl Res. 2015 Nov;166(5):401-11. doi: 10.1016/j.trsl.2015.06.015. Epub 2015 Jul 8. | |
| 26174313 | Derived | Eisenberg Y, Mohiuddin H, Cherukupally K, Zaidi H, Kukreja S, Barengolts E. Similarities and differences between patients included and excluded from a randomized clinical trial of vitamin D supplementation for improving glucose tolerance in prediabetes: interpreting broader applicability. Trials. 2015 Jul 15;16:306. doi: 10.1186/s13063-015-0812-0. |
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Participants were recruited among African American Male veterans coming for medical care to Jesse Brown VA Medical Center in Chicago between May 2011 and December 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | supplement of vitamin D 400 units provided to all subjects in addition to placebo. |
| FG001 | 50K Vitamin D2 | supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Supplement of vitamin D 400 units provided to all subjects in addition to placebo. |
| BG001 | 50K Vitamin D2 | Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Oral Glucose Insulin Sensitivity (OGIS) | Oral glucose insulin sensitivity = index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The primary outcome was the change in oral glucose insulin sensitivity (OGIS, from oral glucose tolerance test) after 12 months of treatment calculated as OGIS at 12-months minus OGIS baseline. | Posted | Mean | Standard Deviation | ml/min/m^2 of body surface area | 12 months |
|
12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Supplement of vitamin D 400 units provided to all subjects in addition to placebo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barengolts, Attending Endocrinologist, Chief, Section of Endocrinology | Jesse Brown VA Medical Center | 312-569-7651 | Elena.Barengolts@va.gov |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 50K vitamin D2 | Drug | Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K |
|
| 12 Months |
| Insulinogenic Index-30 | Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test. Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952) | 12 Month |
| C-Peptidogenic Index-30 | Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test. Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min - fasting C-peptide)/(glucose at 30 min - fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.) | 12 Month |
| Incident Diabetes | 12 Months |
| 25716637 | Derived | Barengolts E, Manickam B, Eisenberg Y, Akbar A, Kukreja S, Ciubotaru I. EFFECT OF HIGH-DOSE VITAMIN D REPLETION ON GLYCEMIC CONTROL IN AFRICAN-AMERICAN MALES WITH PREDIABETES AND HYPOVITAMINOSIS D. Endocr Pract. 2015 Jun;21(6):604-12. doi: 10.4158/EP14548.OR. Epub 2015 Feb 25. |
| BG002 | Total | Total of all reporting groups |
| participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | Kg/m2 |
|
| HbA1c | Mean | Standard Deviation | Percentage of A1C |
|
| Vit D | Mean | Standard Deviation | ng/ml |
|
Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K. |
|
|
|
| Secondary | Change in HbA1c From Baseline at 12 Months | Posted | Mean | Standard Deviation | percentage of A1C | Baseline and 12 Months |
|
|
|
|
| Secondary | Insulin Sensitivity by Matsuda Composite | Insulin Sensitivity by Matsuda Composite - index of insulin sensitivity, higher index means higher insulin sensitivity. Low insulin sensitivity means high insulin resistance and high risk of type 2 diabetes mellitus. It is calculated by a special formula using insulin and glucose measured in Oral Glucose Tolerance test. The formula is different from a formula for OGIS. Matsuda composite calculated based on formula 10^4/Square Root of [(fasting glucose x fasting insulin) x (mean glucose x mean insulin)] (Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic glucose clamp. Diabetes Care. 1999;22:1462-1470) Unit of measure is 10000/√[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)]. | Posted | Mean | Standard Deviation | 10^4/√[(µU/mL)/(mg/dL)x(µU/mL)/(mg/dL)] | 12 Months |
|
|
|
|
| Secondary | Insulinogenic Index-30 | Index of insulin secretion, higher index means higher insulin secretion. It is calculated by a special formula using insulin and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test. Insulin secretion was assessed based on formula Insulinogenic index-30 [(insulin at 30 min - fasting insulin)/(glucose at 30 min - fasting glucose)] (Kosaka K, Hagura R, Kuzuya T. Insulin responses in equivocal and definite diabetes, with special reference to subjects who had mild glucose intolerance but later developed definite diabetes. Diabetes. 1977;26:944-952) | Posted | Mean | Standard Deviation | (µU/mL)/(mg/dL) | 12 Month |
|
|
|
|
| Secondary | C-Peptidogenic Index-30 | Index of insulin secretion, higher index means higher insulin secretion. C-peptide circulates in blood in amounts equal to insulin because insulin and C-peptide are linked when first made by the pancreas. C-peptide is more stable in blood than insulin; therefore it can be reliably used to evaluate insulin secretion. It is calculated by a special formula using C-peptide and glucose measured at 0 min and at 30 min (hence 30 in the name) in Oral Glucose Tolerance test. Insulin secretion was assessed based on formula C-Peptidogenic index-30 [(C-Peptide at 30 min - fasting C-peptide)/(glucose at 30 min - fasting glucose)]Bergstrom RW, Wahl PW, Leonetti DL, Fujimoto WY. Association of fasting glucose levels with a delayed secretion of insulin after oral glucose in subjects with glucose intolerance. J Clin Endocrinol Metab. 1990;71:1447-1453.) | Posted | Mean | Standard Deviation | (ng/mL)/(mg/dL) | 12 Month |
|
|
|
|
| Post-Hoc | Change in Glycemia | Posted | Number | percentage of participants | 12 Months |
|
|
|
|
| Secondary | Incident Diabetes | Posted | Number | participants | 12 Months |
|
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| EG001 | 50K Vitamin D2 | Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K. | 0 | 87 | 0 | 87 |
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