A Study to Evaluate the Effect of 1,25-Dihydroxyvitamin D3 to Treat Insulin Secretion and Muscle Strength in Pre-diabetics

Overview

About this study

The purpose 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 subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults, 20 - 45 years old, inclusive.
  • Body mass index (BMI) of > 24 kg/m^2.
  • Fasting serum glucose < 126 mg/dl.

Exclusion Criteria:

  • BMI ≤ 24 kg/m^2.
  • Fasting serum glucose ≥ 126 mg/dl.
  • Currently taking calcium and/or vitamin D supplements and unwilling to stop for study duration.
  • Serum total calcium > 10.2 mg/dL.
  • Serum inorganic phosphorus > 4.5 mg/dL.
  • Pregnancy or breastfeeding.
  • Diagnosis of Diabetes Mellitus.
  • Diagnosis of Rheumatoid Arthritis.
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD).
  • Renal insufficiency/failure (serum creatinine >1.5 mg/dl men; >1.3 mg/dl women).
  • Chronic active liver disease (bilirubin > 1.2 mg/dL, AST > 144 IU/L, or ALT > 165 IU/L).
  • History of chronic hepatitis.
  • History of depression, anxiety or psychiatric disease.
  • Active coronary artery disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment).
  • Oral warfarin 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 10 mIU/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.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Kumar, M.D.

Open for enrollment

Contact information:

Christine Huyber CCRP

(507) 266-0984

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492859

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