Glucose Intolerance, Metabolic Syndrome, Type 2 Diabetes Mellitus
Conditions
Keywords
Glucose intolerance, Type 2 diabetes mellitus, Metabolic syndrome
Brief summary
The purpose of the randomized trial is to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for type 2 diabetes.
Detailed description
There is animal and human observational evidence to suggest that vitamin D and calcium are important in modifying t2DM risk but there are critical gaps in our knowledge about the clinical magnitude of the association with t2DM and potential mechanisms in humans. We are conducting a randomized trial to quantify the effect of vitamin D and calcium supplementation on beta-cell function, insulin sensitivity, glucose tolerance and systemic inflammation and other cardiometabolic outcomes in ambulatory adults at high risk for t2DM. We anticipate that the research proposed in this application is significant because it will provide the basis for defining feasible nutritional interventions that promotes prevention of t2DM. Based on the results of the proposed studies and future work in this area, vitamin D and calcium supplementation can assume an important role in the treatment of t2DM and in the prevention of the disease in the 41 million Americans who are at risk of developing t2DM.
Interventions
DRUGVitamin D3 2,000 IU orally once daily
Vitamin D3 2,000 IU orally once daily
DRUGCalcium Carbonate 400 mg orally twice daily
Calcium Carbonate 400 mg orally twice daily
DRUGVitamin D3-Placebo
Vitamin D3-Placebo
DRUGCalcium-Placebo
Calcium-Placebo
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ethnicity: all ethnic groups * Gender: men and women * Age 1. Lower age limit: 40 years inclusive 2. Upper age limit: NONE * BMI 1. Lower BMI limit: 25 inclusive 2. Upper BMI limit: 40 inclusive * Glucose Intolerance / Mild Diabetes defined as 1. Fasting glucose ≥100 mg/dl OR 2. 2-hr glucose after OGTT ≥140 mg/dl OR 3. 5.8 ≤ Hemoglobin A1c ≤ 7 Major
Exclusion criteria
* Diabetes requiring pharmacotherapy * Smoking * Hyperparathyroidism * Hypercalcemia (Calcium \> 10.5 mg/dl) * Kidney stone * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chang in Disposition Index, a Measure of Beta Cell Function | baseline and 4 months | Range is 0 to infinity Lower is better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | Baseline to 4 months | This outcome measures change in Hemoglobin A1c, a measure of glycemia |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D-Calcium Vitamin D3 2,000 IU daily plus Calcium Carbonate 400 mg twice daily | 23 |
| Vitamin D Only Vitamin D3 2,000 IU daily plus Calcium-Placebo twice daily | 23 |
| Calcium Only Vitamin D3-Placebo plus Calcium Carbonate 400 mg twice daily | 22 |
| Placebo-Placebo Vitamin D3-Placebo plus Calcium-Placebo | 24 |
| Total | 92 |
Baseline characteristics
| Characteristic | Vitamin D Only | Calcium Only | Vitamin D-Calcium | Placebo-Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 23 Participants | 24 Participants | 92 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 2 | 57 years STANDARD_DEVIATION 2 | 57 years STANDARD_DEVIATION 2 | 59 years STANDARD_DEVIATION 2 | 57 years STANDARD_DEVIATION 1 |
| Region of Enrollment United States | 23 Participants | 22 Participants | 23 Participants | 24 Participants | 92 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 12 Participants | 13 Participants | 47 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 11 Participants | 11 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 23 | 4 / 23 | 5 / 22 | 4 / 24 |
| serious Total, serious adverse events | 1 / 23 | 0 / 23 | 1 / 22 | 0 / 24 |
Outcome results
Primary
Chang in Disposition Index, a Measure of Beta Cell Function
Range is 0 to infinity Lower is better.
Time frame: baseline and 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D-Calcium | Chang in Disposition Index, a Measure of Beta Cell Function | 287 units on a scale | Standard Error 170 |
| Vitamin D Only | Chang in Disposition Index, a Measure of Beta Cell Function | 314 units on a scale | Standard Error 183 |
| Calcium Only | Chang in Disposition Index, a Measure of Beta Cell Function | -122 units on a scale | Standard Error 177 |
| Placebo-Placebo | Chang in Disposition Index, a Measure of Beta Cell Function | -129 units on a scale | Standard Error 174 |
Secondary
Change in Hemoglobin A1c
This outcome measures change in Hemoglobin A1c, a measure of glycemia
Time frame: Baseline to 4 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D-Calcium | Change in Hemoglobin A1c | 0.05 % of hemoglobin | Standard Error 0.05 |
| Vitamin D Only | Change in Hemoglobin A1c | 0.08 % of hemoglobin | Standard Error 0.05 |
| Calcium Only | Change in Hemoglobin A1c | 0.09 % of hemoglobin | Standard Error 0.05 |
| Placebo-Placebo | Change in Hemoglobin A1c | 0.18 % of hemoglobin | Standard Error 0.04 |