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Molecular Regulation of Muscle Glucose Metabolism | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Molecular Regulation of Muscle Glucose Metabolism

NCT01581736•Mayo Clinic

Summary

This protocol is being conducted to determine the mechanisms responsible for insulin resistance, obesity and type 2 diabetes.

Detailed Description

This protocol involves performance of a hyperinsulinemic euglycemic clamp with 2 muscle biopsies and an exercise study with a muscle biopsy.

Eligibility

Age

30 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
•2. Subjects may be of either sex, age as described in each protocol. Female subjects must be non-lactating and must either be at least two years post-menopausal, (if diabetic or obese) or be using adequate contraceptive precautions (i.e. oral contraceptives, approved hormonal implant, intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients (except for those patients who have undergone a hysterectomy or bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period.
•3. Subjects must range in age as described in each specific protocol.
•4. All nondiabetic subjects must have normal oral glucose tolerance.
•5. Subjects must have the following laboratory values:
•1. Hematocrit ≥ 35 vol%
•2. Serum creatinine ≤ 1.6 mg/dl
•3. Aspartate aminotransferase (AST) (SGOT) \< 2 times upper limit of normal
•4. Alanine aminotransferase (ALT) (SGPT) \< 2 times upper limit of normal
•5. Alkaline phosphatase \< 2 times upper limit of normal
+3 more criteria

Exclusion Criteria

•1. Subjects must not be receiving any of the following medications: thiazide or furosemide diuretics, beta-blockers, or other chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on stable dose of such agents for the past three months before entry into the study. Subjects may be taking a stable dose of estrogens or other hormonal replacement therapy, if the subject has been on these agents for the prior three months. Subjects taking systemic glucocorticoids are excluded.
•2. Subjects with a history of 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), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation) will not be studied.
•3. Recent systemic or pulmonary embolus, untreated high-risk proliferative retinopathy, recent retinal hemorrhage, uncontrolled hypertension, systolic BP \> 180, diastolic BP \> 105, autonomic neuropathy, resting heart rate \> 100, electrolyte abnormalities.

Locations (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

November 27, 2017

Enrollment

ACTUAL participants

Conditions

ObesityType 2 Diabetes Mellitus

Interventions

U100 Humulin

DRUG

Exercise

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Molecular Regulation of Muscle Glucose Metabolism

Inclusion Criteria

Exclusion Criteria

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