Impaired Fasting GlucoseDIVANCT01375660
D Vitamin Intervention in VA
A study testing 50K vitamin D2 in people with Impaired Fasting Glucose and Impaired Glucose Tolerance, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years, men only
- Conditions the study is for
- Impaired Fasting Glucose, Impaired Glucose Tolerance, Vitamin D Insufficiency
- What is being tested?
- 50K vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
About this study
Official title: Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes
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.
Read the 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.
- Being tested
- Placebo, 50K vitamin D2
- Keywords
- Vitamin D, Glucose intolerance, African American men
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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 D2Drug
Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | Placebo: One capsule weekly Receives: Drug: Placebo |
| Arm 2 | Experimental | 50K vitamin D2: One capsule weekly Receives: Drug: 50K vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Change in HbA1c From Baseline at 12 Months
Measured: 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)].
Measured: 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)
Measured: 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.)
Measured: 12 Month
Incident Diabetes
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Impaired Fasting GlucoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Elena I. Barengolts, MD, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375660
- Sponsor's protocol ID
- CLIN-001-10S
- Acronym
- DIVA
- Status last verified
- Feb 2015
- First submitted
- 15 Jun 2011
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 26209747Eisenberg 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.
PubMed 26174313Barengolts 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.
PubMed 25716637
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Deficiency and Treatment in Male Veterans at Risk for Diabetes
- ClinicalTrials.gov ID
- NCT01375660
- Acronym / sponsor ID
- DIVA / CLIN-001-10S
- Keywords
- Vitamin D, Glucose intolerance, African American men
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Jun 2011 (estimated)
- Results
- Posted 5 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: PlaceboPlacebo: One capsule weekly |
| Arm 2 | Experimental | Drug: 50K vitamin D250K vitamin D2: One capsule weekly |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Veterans at Jesse Brown VA Medical Center (JBVAMC) only
- Male
- African American race
- Age 35-85 years
- BMI 28-39.9 kg/m2
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSupplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K | Drug | Arm 1 |
| 50K vitamin D2Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K | Drug | Arm 2 |
Primary outcome
Oral Glucose Insulin Sensitivity (OGIS)
Time frame: 12 months
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.
5 secondary outcomes
Change in HbA1c From Baseline at 12 Months
Time frame: Baseline and 12 Months
Insulin Sensitivity by Matsuda Composite
Time frame: 12 Months
Insulinogenic Index-30
Time frame: 12 Month
C-Peptidogenic Index-30
Time frame: 12 Month
Incident Diabetes
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26209747Ciubotaru 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.
- Derived from this study: PubMed 26174313Eisenberg 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.
- Derived from this study: PubMed 25716637Barengolts 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena I. Barengolts, MD principal investigator
Jesse Brown VA Medical Center, Chicago, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50K vitamin D2 in people with Impaired Fasting Glucose and Impaired Glucose Tolerance, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Glucose Insulin Sensitivity (OGIS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01375660, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.