Insulin Signaling in Skeletal Muscle

Insulin Sensitivity Clinical Trial

Official title:

Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03452267
• Other study ID #: MetPioMuscle
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: September 1, 2019
• Est. completion date: June 2025

Study information

• Verified date: October 2020
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Sensitivity

Intervention

Drug:
• Metformin
oral, 850 mg twice daily
• Pioglitazone
oral, 45 mg daily
• Placebo
oral, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteomic	Changes in global protein abundance levels	3 months
Primary	Proteomic 2	Changes in global protein phosphorylation levels	3 months
Secondary	Epigenomic	Change in global DNA percent methylation	3 months