Insulin Sensitivity
Conditions
Keywords
vitamin D deficiency, insulin sensitivity
Brief summary
Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.
Interventions
DRUGErgocalciferols
ERgocaclciferol 50,000 units weekly for 8 weeks
DRUGPlacebo
matching placebo
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Age 18-60 years 2. No known medical illnesses requiring pharmacotherapy 3. Not on any mineral or vitamin supplements in the last 3 months
Exclusion criteria
* 1\. Subjects requiring prompt initiation of pharmacotherapy, such as those with incidentally discovered diabetes mellitus or hypertension. 2\. Previous administration of glucocorticoids, retinoic acid derivatives, or insulin sensitizers in the preceding 3 months. 3\. Bariatric surgery or liposuction 4. Unintentional weight loss \>5% of the body weight in last 3 months 5. Chronic smokers (\> 1 pk/d for 10 years) 6. Alcohol use \> 2 drinks/day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M Value (Insulin Stimulated Glucose Uptake) | Baseline and at 8 weeks | Insulin stimulated glucose uptake will be measured by glucose clamp studies |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D ERgocalcifoerol 50,000 units q weekly for 8 weeks | 6 |
| Placebo Matching placebo q weekly for 8 weeks | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Total | Vitamin D | Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 6 Participants | 6 Participants |
| Age, Continuous | 28.4 years STANDARD_DEVIATION 3.2 | 29 years STANDARD_DEVIATION 3.6 | 27.8 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment United States | 12 participants | 6 participants | 6 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 8 Participants | 4 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 |
Outcome results
Primary
M Value (Insulin Stimulated Glucose Uptake)
Insulin stimulated glucose uptake will be measured by glucose clamp studies
Time frame: Baseline and at 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vitamin D | M Value (Insulin Stimulated Glucose Uptake) | Baseline | 4.1 mg/kg.min | Standard Deviation 1.56 |
| Vitamin D | M Value (Insulin Stimulated Glucose Uptake) | 8 weeks | 4.7 mg/kg.min | Standard Deviation 1.35 |
| Placebo | M Value (Insulin Stimulated Glucose Uptake) | Baseline | 5.6 mg/kg.min | Standard Deviation 1.48 |
| Placebo | M Value (Insulin Stimulated Glucose Uptake) | 8 weeks | 5.5 mg/kg.min | Standard Deviation 1.68 |
p-value: 0.4t-test, 2 sided