A Study to Evaluate the Effect of 1,25-Dihydroxyvitamin D3 to Treat Insulin Secretion and Muscle Strength in Pre-diabetics
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-010890
NCT ID: NCT04286529
Sponsor Protocol Number: 19-010890
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Rajiv Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available