Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

Study Overview
=================
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.

Official Title
-----------------
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

Conditions
-----------------
Pre-Diabetic

Intervention / Treatment
-----------------
* Drug: Calcitriol capsules
* Drug: Oral Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Men-Calcitriol<br>Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. | Drug: Calcitriol capsules<br>* 0.25micrograms, taken daily for eight weeks, orally<br>|
| Active Comparator: Premenopausal Women-Calcitriol<br>Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks. | Drug: Calcitriol capsules<br>* 0.25micrograms, taken daily for eight weeks, orally<br>|
| Placebo Comparator: Men-Placebo<br>0.25mcg capsule daily for eight weeks | Drug: Oral Placebo<br>* Placebo will be created to mimic the appearance of the study drug<br>|
| Placebo Comparator: Premenopausal Women-Placebo<br>0.25mcg capsule daily for eight weeks | Drug: Oral Placebo<br>* Placebo will be created to mimic the appearance of the study drug<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and 8 weeks | 
| 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. | Baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS 10 Questionnaire | Brief 10 question multiple choice survey | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-menopausal women