Molecular Regulation of Muscle Glucose Metabolism

Obesity Clinical Trial

Official title:

Molecular Regulation of Muscle Glucose Metabolism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01581736
• Other study ID #: 11-004005
• Status: Terminated
• Phase: Phase 1
• First received: February 15, 2012
• Last updated: November 22, 2017
• Start date: April 2012
• Est. completion date: April 2016

Study information

• Verified date: November 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

6. Triglycerides < 150 mg/dl.

7. Prothrombin time (PT) 11.7 -14.3 (During Liposyn/heparin infusion, PT will be determined to insure that it is < 1.5-2.0 times the normal value.)

8. Partial thromboplastin time (PTT) 23.0-37.0.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Drug:
• U100 Humulin
Infused at a rate of 80/mU/m2 surface area per minute one time over 2 hours

Other:
• Exercise
Single episode of exercise riding a stationary bike.

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity	euglycemic clamp	one month from date of volunteer study
Secondary	acetylation of mitochondrial adenine nucleotide translocase	proteomics analysis of post translational modification of proteins obtained from isolated mitochondria	within 6 months of volunteer study