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

Pre-Diabetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04286529
• Other study ID #: 19-010890
• Status: Terminated
• Phase: Phase 1
• Start date: October 1, 2020
• Est. completion date: May 28, 2021

Study information

• Verified date: February 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: May 28, 2021
• Est. primary completion date: May 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

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

Related Conditions & MeSH terms

• Pre-Diabetic
• Prediabetic State

Intervention

Drug:
• Calcitriol capsules
0.25micrograms, taken daily for eight weeks, orally
• Oral Placebo
Placebo will be created to mimic the appearance of the study drug

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose Levels	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.	Baseline and 8 weeks
Primary	Insulin Level	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.	Baseline and 8 weeks
Primary	C-Peptide Level	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.	Baseline and 8 weeks
Secondary	PROMIS 10 Questionnaire	Brief 10 question multiple choice survey	8 weeks

External Links

•   Mayo Clinic Clinical Trials