Insulin Signaling in Skeletal Muscle

NCT ID: NCT03452267

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2025-06-30

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.

Conditions

Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

oral, 850 mg twice daily

Pioglitazone

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

oral, 45 mg daily

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral, once daily

Interventions

Metformin

oral, 850 mg twice daily

Intervention Type: DRUG

Pioglitazone

oral, 45 mg daily

Intervention Type: DRUG

Placebo

oral, once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Kyle Jon Burghardt, Pharm.D.

Assistant Professor of Pharmacy Practice

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MetPioMuscle

Identifier Type: -

Identifier Source: org_study_id