Status:
TERMINATED
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Lead Sponsor:
Mayo Clinic
Conditions:
Pre-Diabetic
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
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 skele...
Eligibility Criteria
Inclusion
- Body mass index (BMI) of \>24kg/m2
- Fasting serum glucose \<126 mg/dL
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04286529
Start Date
October 1 2020
End Date
May 28 2021
Last Update
April 18 2022
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905