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Insulin Signaling in Skeletal Muscle

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ClinicalTrials.gov Identifier: NCT03452267
Recruitment Status : Not yet recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Kyle Burghardt, Wayne State University

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
Insulin Sensitivity Drug: Metformin Drug: Pioglitazone Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Proteomic [ Time Frame: 3 months ]
    Changes in global protein abundance levels

  2. Proteomic 2 [ Time Frame: 3 months ]
    Changes in global protein phosphorylation levels


Secondary Outcome Measures :
  1. Epigenomic [ Time Frame: 3 months ]
    Change in global DNA percent methylation



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

Responsible Party: Kyle Burghardt, Assistant Professor of Pharmacy Practice, Wayne State University
ClinicalTrials.gov Identifier: NCT03452267     History of Changes
Other Study ID Numbers: MetPioMuscle
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs