Pre-Diabetic
Conditions
Keywords
Pre-menopausal women
Brief summary
The purpose of this research is to study the effects of 1,25(OH)2 D3 (a prescription form of active Vitamin D) on muscle strength and insulin secretion by the pancreas and glucose utilization by skeletal muscle.
Interventions
0.25micrograms, taken daily for eight weeks, orally
DRUGOral Placebo
Placebo will be created to mimic the appearance of the study drug
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) of \>24kg/m2 * Fasting serum glucose \<126 mg/dL
Exclusion criteria
* BMI\</=24 kg/m2 * Fasting serum glucose \>/=126 mg/dL * Patient is taking Calcium or Vitamin D supplements and is unwilling to stop for 8 weeks * Serum Calcium \>10.2 mg/dL * Serum inorganic phosphorous \>4.5mg/dL * Pregnancy or breastfeeding * Diagnosis of Diabetes Mellitus * Diagnosis of Rheumatoid Arthritis * Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) * Renal in sufficiency/failure ( serum creatinine \>1.5 mg/dL men, \> 1.3 mg/dL women) * Chronic active liver disease (bilirubin \>1.2 mg/dL, AST\>144IU/L, or ALT \>165 IU/L) * History of chronic hepatitis * Active coronary artery disease ( unstable angina, myocardial infarction, stroke and revascularization of coronary, peripheral or carotid artery within the last 3 months) * Oral warfarin group medications or history of blood clotting disorders * Platelet count \<100,000 per uL within the last 7 days * Alcohol consumption greater than 2 glasses/day or other substance abuse * Untreated or uncontrolled thyroid disorders (outside a TSH range of 0.5 to 10mIU/L) * Debilitating chronic disease (at the discretion of the investigators) * The presence of infections, highly communicable diseases ( AIDS, active tuberculosis, venereal disease, hepatitis) * Any malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Levels | Baseline and 8 weeks | Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. |
| Insulin Level | Baseline and 8 weeks | Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. |
| C-Peptide Level | Baseline and 8 weeks | Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS 10 Questionnaire | 8 weeks | Brief 10 question multiple choice survey |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Men-Calcitriol Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally | 4 |
| Premenopausal Women-Calcitriol Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Calcitriol capsules: 0.25micrograms, taken daily for eight weeks, orally | 4 |
| Men-Placebo 0.25mcg capsule daily for eight weeks
Oral Placebo: Placebo will be created to mimic the appearance of the study drug | 5 |
| Premenopausal Women-Placebo 0.25mcg capsule daily for eight weeks
Oral Placebo: Placebo will be created to mimic the appearance of the study drug | 4 |
| Total | 17 |
Baseline characteristics
| Characteristic | Men-Calcitriol | Premenopausal Women-Calcitriol | Men-Placebo | Premenopausal Women-Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 4.2 | 29 years STANDARD_DEVIATION 5.2 | 30 years STANDARD_DEVIATION 2.6 | 27 years STANDARD_DEVIATION 2.6 | 30 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 5 participants | 4 participants | 17 participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 0 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 5 Participants | 0 Participants | 9 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 | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
C-Peptide Level
Blood will be obtained to measure c-peptide level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Men-Calcitriol | C-Peptide Level | Baseline | 0.6 nmol/L | Standard Deviation 0.07 |
| Men-Calcitriol | C-Peptide Level | 8 Weeks | 0.74 nmol/L | Standard Deviation 0.07 |
| Premenopausal Women-Calcitriol | C-Peptide Level | 8 Weeks | 0.55 nmol/L | Standard Deviation 0 |
| Premenopausal Women-Calcitriol | C-Peptide Level | Baseline | 0.5 nmol/L | Standard Deviation 0 |
| Men-Placebo | C-Peptide Level | 8 Weeks | 0.49 nmol/L | Standard Deviation 0.08 |
| Men-Placebo | C-Peptide Level | Baseline | 0.7 nmol/L | Standard Deviation 0.3 |
| Premenopausal Women-Placebo | C-Peptide Level | 8 Weeks | 0.52 nmol/L | Standard Deviation 0 |
| Premenopausal Women-Placebo | C-Peptide Level | Baseline | 0.5 nmol/L | Standard Deviation 0 |
Primary
Glucose Levels
Blood will be obtained to measure glucose after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Time frame: Baseline and 8 weeks
Population: Data not collected or analyzed at 8 weeks for the one participant in the Premenopausal Women-Placebo study arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Men-Calcitriol | Glucose Levels | 8 weeks | 98 mg/dL | Standard Deviation 9.2 |
| Men-Calcitriol | Glucose Levels | Baseline | 90 mg/dL | Standard Deviation 4.1 |
| Premenopausal Women-Calcitriol | Glucose Levels | Baseline | 76 mg/dL | Standard Deviation 0 |
| Premenopausal Women-Calcitriol | Glucose Levels | 8 weeks | 85 mg/dL | Standard Deviation 0 |
| Men-Placebo | Glucose Levels | Baseline | 89 mg/dL | Standard Deviation 4 |
| Men-Placebo | Glucose Levels | 8 weeks | 85 mg/dL | Standard Deviation 4.7 |
| Premenopausal Women-Placebo | Glucose Levels | Baseline | 82 mg/dL | Standard Deviation 0 |
Primary
Insulin Level
Blood will be obtained to measure insulin level after a glucose tolerance test. The glucose tolerance test involves an overnight fast and then participants will ingest a drink containing 75 grams of glucose with blood obtained over a 120 minute period.
Time frame: Baseline and 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Men-Calcitriol | Insulin Level | Baseline | 4.7 uIU/mL | Standard Deviation 1.8 |
| Men-Calcitriol | Insulin Level | 8 Weeks | 5 uIU/mL | Standard Deviation 1.8 |
| Premenopausal Women-Calcitriol | Insulin Level | 8 Weeks | 4 uIU/mL | Standard Deviation 0 |
| Premenopausal Women-Calcitriol | Insulin Level | Baseline | 4.6 uIU/mL | Standard Deviation 0 |
| Men-Placebo | Insulin Level | Baseline | 3 uIU/mL | Standard Deviation 1.6 |
| Men-Placebo | Insulin Level | 8 Weeks | 3 uIU/mL | Standard Deviation 0.8 |
| Premenopausal Women-Placebo | Insulin Level | Baseline | 2.4 uIU/mL | Standard Deviation 0 |
| Premenopausal Women-Placebo | Insulin Level | 8 Weeks | 4 uIU/mL | Standard Deviation 0 |
Secondary
PROMIS 10 Questionnaire
Brief 10 question multiple choice survey
Time frame: 8 weeks
Population: Data not collected or analyzed