D Vitamin Intervention in VA

Impaired Glucose Tolerance Clinical Trial

— DIVA  

Official title:

Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01375660
• Other study ID #: CLIN-001-10S
• Status: Completed
• Phase: N/A
• First received: June 15, 2011
• Last updated: February 17, 2015
• Start date: May 2011
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

Veterans at Jesse Brown VA Medical Center (JBVAMC) only

• Male

• African American race

• Age 35-85 years

• BMI 28-39.9 kg/m2

• Stable weight (+/- 10%) for at least 3 months prior to study entry

• FPG 95 - 125 mg/dl

• A1C 5.7 - 6.4%

• Circulating 25OHD 5.0 - 29.9 ng/ml

• Subjects who take ergocalciferol are allowed in the study after a washout period 1 3 month.

• Subjects who take vitamin D supplements other than ergocalciferol are allowed in the study as long as total dose is no more than 600 IU/day (including MVI and calcium plus D supplements).

• Non-diabetic subjects who are diagnosed with T2DM during screening (A1C 6.5-7%) or after randomization are allowed to continue if they follow lifestyle intervention and do not need to take anti-diabetic medications.

Exclusion Criteria:

• Subjects with T2DM

• Weight gain or loss of more than 10% within 3 months prior to the study entry

• History of kidney stones, hyperparathyroidism, sarcoidosis or hypercalcemia

• A1C >7%.

• Very low 25OHD levels (<5 ng/ml) and/or the presence of a physical consequence of very low vitamin D levels (hypocalcemia, hypophosphatemia, proximal muscle weakness)

• Chronic kidney disease (CKD) stage 4 and 5

• Problems that in the judgment of PI may be associated with the risk to the subject or non-compliance

• Subjects who take vitamin D supplements and not willing to go through washout period for ergocalciferol or to take no more than 600 IU/day of total vitamin D supplements

• History, clinical manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject

• Non-diabetic subjects who are diagnosed with T2DM after randomization and need to take anti-diabetic medications are brought for the final visit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Fasting Glucose
• Impaired Glucose Tolerance
• Vitamin D Insufficiency

Intervention

Drug:
• Placebo
Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
• 50K vitamin D2
Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K

Locations

Country	Name	City	State
United States	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months	No
Secondary	Change in HbA1c From Baseline at 12 Months		Baseline and 12 Months	No
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/v[(µU/mL)/(mg/dL)]x[(µU/mL)/(mg/dL)].	12 Months	No
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)	12 Month	No
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.)	12 Month	No
Secondary	Incident Diabetes		12 Months	No