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

Primary Purpose

Pre-Diabetic

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Calcitriol capsules
Oral Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-Diabetic focused on measuring Pre-menopausal women

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Placebo Comparator

Arm Label

Men-Calcitriol

Premenopausal Women-Calcitriol

Men-Placebo

Premenopausal Women-Placebo

Arm Description

Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.

Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.

0.25mcg capsule daily for eight weeks

0.25mcg capsule daily for eight weeks

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

PROMIS 10 Questionnaire
Brief 10 question multiple choice survey

Full Information

First Posted
February 25, 2020
Last Updated
February 17, 2022
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04286529
Brief Title
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Official Title
Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with study logistics due to COVID-19
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
May 28, 2021 (Actual)
Study Completion Date
May 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Diabetic
Keywords
Pre-menopausal women

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Men-Calcitriol
Arm Type
Active Comparator
Arm Description
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Arm Title
Premenopausal Women-Calcitriol
Arm Type
Active Comparator
Arm Description
Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.
Arm Title
Men-Placebo
Arm Type
Placebo Comparator
Arm Description
0.25mcg capsule daily for eight weeks
Arm Title
Premenopausal Women-Placebo
Arm Type
Placebo Comparator
Arm Description
0.25mcg capsule daily for eight weeks
Intervention Type
Drug
Intervention Name(s)
Calcitriol capsules
Intervention Description
0.25micrograms, taken daily for eight weeks, orally
Intervention Type
Drug
Intervention Name(s)
Oral Placebo
Intervention Description
Placebo will be created to mimic the appearance of the study drug
Primary Outcome Measure Information:
Title
Glucose Levels
Description
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.
Time Frame
Baseline and 8 weeks
Title
Insulin Level
Description
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.
Time Frame
Baseline and 8 weeks
Title
C-Peptide Level
Description
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.
Time Frame
Baseline and 8 weeks
Secondary Outcome Measure Information:
Title
PROMIS 10 Questionnaire
Description
Brief 10 question multiple choice survey
Time Frame
8 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Menopausal status is of interest to the study.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajiv Kumar, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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