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Insulin Signaling in Skeletal Muscle

Sponsor
Wayne State University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03452267
Collaborator
(none)
0
Enrollment
3
Arms
69
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Metformin and Pioglitazone on Insulin Signaling in Skeletal Muscle
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Metformin

Drug: Metformin
oral, 850 mg twice daily
Experimental: Pioglitazone

Drug: Pioglitazone
oral, 45 mg daily
Placebo Comparator: Placebo

Drug: Placebo
oral, once daily

Outcome Measures

Primary Outcome Measures

  1. Proteomic [3 months]

    Changes in global protein abundance levels

  2. Proteomic 2 [3 months]

    Changes in global protein phosphorylation levels

Secondary Outcome Measures

  1. Epigenomic [3 months]

    Change in global DNA percent methylation

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Wayne State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kyle Jon Burghardt, Pharm.D., Assistant Professor of Pharmacy Practice, Wayne State University
ClinicalTrials.gov Identifier:
NCT03452267
Other Study ID Numbers:
  • MetPioMuscle
First Posted:
Mar 2, 2018
Last Update Posted:
Oct 8, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Insulin Resistance
Metformin
Pioglitazone

Study Results

No Results Posted as of Oct 8, 2020