Effect of Age on Glucose and Lipid Metabolism

NCT01737164 | Completed

• 2 other identifiers: HSC20100133H1R01DK089229-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Aging is a major risk factor for the development of type 2 diabetes (T2DM). Approximately 50% of subjects aged ≥65 have diabetes or impaired glucose tolerance, a pre-diabetic state. Purpose: In the proposed study, the investigators will test the hypotheses that the decrease in fat oxidation that occurs in muscle from older human subjects is secondary to an age-mediated reduction in AMPK signaling, in vivo, and that upregulating AMPK signaling through exercise training will result in (and correlate with) increased fat oxidation, reduced intramyocellular lipids, and improved insulin action.

Conditions

Glucose Metabolism Disorders; Lipid Metabolism Disorders; Metabolic Diseases

Keywords

Glucose; Lipid; Metabolism; Non Diabetic; Healthy

Outcome Measures

Primary Outcomes (1)

• Effect of Age on Glucose and Lipid Metabolism

  Effect of Age on Glucose and Lipid Metabolism; Measurement of glucose and lipid metabolism will be done pre and post exercise in two groups (younger and older subjects)

  16 weeks

Study Arms (2)

Aerobic Exercise - Older Subjects

EXPERIMENTAL

Subjects aged 65 and higher will perform 16 weeks of moderate intensity exercise

Behavioral: Aerobic Exercise

Aerobic Exercise - Young Subjects

EXPERIMENTAL

Subjects 18-30 years old will perform 16 weeks of moderate intensity exercise

Behavioral: Aerobic Exercise

Interventions

Aerobic Exercise BEHAVIORAL

Aerobic Exercise - Older Subjects; Aerobic Exercise - Young Subjects

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy, normally active, younger (18-30 y), normal glucose tolerant subjects, without a family history of T2DM (neither parent nor siblings), and BMI of 23-26 kg/m2.
• healthy, normally active, older (≥65 y), normal glucose tolerant subjects without a family history of T2DM, and BMI of 23-26 kg/m2.
• Women must be non-lactating. Female patients are eligible only if they have a negative pregnancy test throughout the study period (or postmenopausal). Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months. In younger menstruating woman, all metabolic studies will be performed on the follicular phase of the menstrual cycle.
• Subjects must have the following laboratory values: Hematocrit ≥ 35%, serum creatinine ≤ 1.5 mg/dl, AST \< 2 X upper limit of normal, ALT \< 2 X upper limit of normal, alkaline phosphatase \< 2 X upper limit of normal, normal urinalysis, and normal platelets, PT and PTT.

You may not qualify if:

• Subjects with diabetes or impaired glucose tolerance based on ADA criteria.
• Subjects taking drugs known to affect glucose and lipid homeostasis will be excluded.
• Patients with a history of heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the ECG), peripheral vascular disease, or pulmonary disease.
• Recent pulmonary embolus, poorly controlled blood pressure (systolic BP\>170, diastolic BP\>95), resting heart rate \>100, electrolyte abnormalities, neuromuscular or musculoskeletal disease.
• Subjects who smoke.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Texas Diabetes Insitute

San Antonio, Texas, 78207, United States

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders; Lipid Metabolism Disorders; Metabolic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nicolas Musi, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: September 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 19, 2016

Record last verified: 2016-02

Locations

US (1)