Insulin Signaling in Skeletal Muscle

• Status: Withdrawn
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wayne State University
• Treatments: Metformin; Pioglitazone

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