Back to resultsInsulin Signaling in Skeletal Muscle
Primary Purpose
Insulin Sensitivity
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Metformin
Pioglitazone
Placebo
Sponsored by
About this trial
This is an interventional other trial for Insulin Sensitivity
Eligibility Criteria
Inclusion Criteria:
- Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
General Inclusion Criteria:
- Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
- Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
Exclusion Criteria:
- Oral glucose tolerance test <140 or >200mg/dL
Treated with any of the following medications:
- Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
- Start or change of hormonal replacement therapy within 3 months prior to screening
- Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
History or presence of any of the following conditions:
- Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
- Peripheral vascular disease (history of claudication)
- Clinically significant pulmonary disease.
- Current uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
- History or presence of malignancy other than basal cell or squamous cell skin cancer
- Autonomic neuropathy
- Clinically significant hematologic disease
Any of the following abnormal laboratory values:
- Hematocrit < 35 vol%
- Serum creatinine > 1.6 mg/dl
- AST, ALT or Alkaline phosphatase > 2.5 times the upper limit of normal
- PT, PTT outside the normal reference range
- TSH outside the normal reference range
- Triglycerides > 400 mg/dl
- Platelet count < 50,000
- Current or history of drug abuse or alcohol abuse
- Blood donation within 2 months prior to screening
- Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
- Diagnosed with Type 1 diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Metformin
Pioglitazone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Proteomic
Changes in global protein abundance levels
Proteomic 2
Changes in global protein phosphorylation levels
Secondary Outcome Measures
Epigenomic
Change in global DNA percent methylation
Full Information
NCT ID
NCT03452267
First Posted
February 12, 2018
Last Updated
October 5, 2020
Sponsor
Wayne State University
1. Study Identification
Unique Protocol Identification Number
NCT03452267
Brief Title
Insulin Signaling in Skeletal Muscle
Official Title
Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wayne State University
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
Yes
5. Study Description
Brief Summary
The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Experimental
Arm Title
Pioglitazone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
oral, 850 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
oral, 45 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, once daily
Primary Outcome Measure Information:
Title
Proteomic
Description
Changes in global protein abundance levels
Time Frame
3 months
Title
Proteomic 2
Description
Changes in global protein phosphorylation levels
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Epigenomic
Description
Change in global DNA percent methylation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
General Inclusion Criteria:
Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
Exclusion Criteria:
Oral glucose tolerance test <140 or >200mg/dL
Treated with any of the following medications:
Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
Start or change of hormonal replacement therapy within 3 months prior to screening
Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
History or presence of any of the following conditions:
Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
Peripheral vascular disease (history of claudication)
Clinically significant pulmonary disease.
Current uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
History or presence of malignancy other than basal cell or squamous cell skin cancer
Autonomic neuropathy
Clinically significant hematologic disease
Any of the following abnormal laboratory values:
Hematocrit < 35 vol%
Serum creatinine > 1.6 mg/dl
AST, ALT or Alkaline phosphatase > 2.5 times the upper limit of normal
PT, PTT outside the normal reference range
TSH outside the normal reference range
Triglycerides > 400 mg/dl
Platelet count < 50,000
Current or history of drug abuse or alcohol abuse
Blood donation within 2 months prior to screening
Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.
Diagnosed with Type 1 diabetes
12. IPD Sharing Statement
Plan to Share IPD
No
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Insulin Signaling in Skeletal Muscle
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