Molecular Regulation of Muscle Glucose Metabolism

NCT01581736 | Terminated Phase 1

• 1 other identifier: 11-004005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Type 2 Diabetes Mellitus

Keywords

insulin resistance; mitochondria

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  euglycemic clamp

  one month from date of volunteer study

Secondary Outcomes (1)

• acetylation of mitochondrial adenine nucleotide translocase

  within 6 months of volunteer study

Study Arms (1)

Exercise

EXPERIMENTAL

Proteomics of muscle after a single bout of exercise compared to baseline with U100 Humulin infusion at rate of 80 milliunits(mU)/m\^2 surface area.

Drug: U100 Humulin; Other: Exercise

Interventions

U100 Humulin DRUG

Infused at a rate of 80/mU/m2 surface area per minute one time over 2 hours

Also known as: Humulin, Human insulin

Exercise

Exercise OTHER

Single episode of exercise riding a stationary bike.

Exercise

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
• 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.
• Subjects must range in age as described in each specific protocol.
• All nondiabetic subjects must have normal oral glucose tolerance.
• Subjects must have the following laboratory values:
• Hematocrit ≥ 35 vol%
• Serum creatinine ≤ 1.6 mg/dl
• Aspartate aminotransferase (AST) (SGOT) \< 2 times upper limit of normal
• Alanine aminotransferase (ALT) (SGPT) \< 2 times upper limit of normal
• Alkaline phosphatase \< 2 times upper limit of normal
• Triglycerides \< 150 mg/dl.
• 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.)
• Partial thromboplastin time (PTT) 23.0-37.0.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Arizona State University: collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Insulin, Regular, Human; Insulin; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lori Roust, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Lawrence J. Mandarino, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Endocrinology

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: April 20, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 27, 2017

Record last verified: 2017-11

Locations

US (1)