D Vitamin Intervention in VA (DIVA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01375660
First received: June 15, 2011
Last updated: February 17, 2015
Last verified: February 2015
  Purpose

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.


Condition Intervention
Impaired Fasting Glucose
Impaired Glucose Tolerance
Vitamin D Insufficiency
Drug: Placebo
Drug: 50K vitamin D2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Oral Glucose Insulin Sensitivity (OGIS) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change in HbA1c From Baseline at 12 Months [ Time Frame: Baseline and 12 Months ] [ Designated as safety issue: No ]
  • Insulin Sensitivity by Matsuda Composite [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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)].


  • Insulinogenic Index-30 [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

    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)


  • C-Peptidogenic Index-30 [ Time Frame: 12 Month ] [ Designated as safety issue: No ]

    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.)


  • Incident Diabetes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 205
Study Start Date: May 2011
Study Completion Date: November 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Placebo: One capsule weekly
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
Experimental: Arm 2
50K vitamin D2: One capsule weekly
Drug: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375660

Locations
United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Elena I. Barengolts, MD Jesse Brown VA Medical Center, Chicago, IL
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01375660     History of Changes
Other Study ID Numbers: CLIN-001-10S
Study First Received: June 15, 2011
Results First Received: November 25, 2014
Last Updated: February 17, 2015
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Vitamin D
Glucose intolerance
African American men

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Hyperglycemia
Metabolic Diseases
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 29, 2015