Insulin Signaling in Skeletal Muscle

NCT03452267 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MetPioMuscle
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Proteomic

  Changes in global protein abundance levels

  3 months

• Proteomic 2

  Changes in global protein phosphorylation levels

  3 months

Secondary Outcomes (1)

• Epigenomic

  3 months

Study Arms (3)

Metformin

EXPERIMENTAL

Drug: Metformin

Pioglitazone

EXPERIMENTAL

Drug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Metformin DRUG

oral, 850 mg twice daily

Metformin

Pioglitazone DRUG

oral, 45 mg daily

Pioglitazone

Placebo DRUG

oral, once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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%

Sponsors & Collaborators

• Wayne State University: lead

MeSH Terms

Conditions

Insulin Resistance

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pharmacy Practice

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 2, 2018
• Study Start: September 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share