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

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

Not Recruiting
20-45 years
All
Phase 1

Overview

The aim of this study is to assess the effects of 1,25(OH)2D3 on insulin secretion by the pancreas and glucose utilization by skeletal muscle as well as to determine the effects of 1,25(OH)2D3 on muscle strength in pre-diabetic persons

Eligibility

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

Study details
    Prediabetes

NCT04286529

Mayo Clinic

16 February 2024

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