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

Phase 1

Terminated

• Conditions: Pre-Diabetic
• Interventions: Drug: Oral Placebo; Drug: Calcitriol capsules

• Registration Number: NCT04286529
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-02-26
• Study First Posted: 2020-02-27
• Study Start: 2020-10-01
• Primary Completion: 2021-05-28
• Study Completion: 2021-05-28
• Results First Submitted: 2021-12-13
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-17
• Last Update Submitted: 2022-02-17
• Results First Posted: 2022-04-18
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Men-Placebo	Oral Placebo	0.25mcg capsule daily for eight weeks
Premenopausal Women-Placebo	Oral Placebo	0.25mcg capsule daily for eight weeks
Men-Calcitriol	Calcitriol capsules	Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Premenopausal Women-Calcitriol	Calcitriol capsules	Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.

Primary Outcome Measures

Name	Time	Method
Glucose Levels	Baseline and 8 weeks	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.
C-Peptide Level	Baseline and 8 weeks	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.
Insulin Level	Baseline and 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
PROMIS 10 Questionnaire	8 weeks	Brief 10 question multiple choice survey

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States