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Muscle Lipid and Insulin Resistance in the Elderly (MIRA)

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Group
Health Education Group
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Insulin Resistance, Obesity, Exercise Training, Physical Activity

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 60 - 70 years of age
  • No weight gain/loss of >10 lbs in 6 months
  • Sedentary (No more than 1 continuous exercise/week) or Highly trained (>5 exercise sessions/week for a duration of one year or more)
  • Non-Smoker
  • BMI 18-38.0
  • Resting blood pressure less than 150mmHg systolic/95 mmHg diastolic
  • Normal glucose tolerance: Fasting glucose < 100 mg/dl or 2 hour glucose from OGTT < 140 mg/dl or impaired glucose tolerance (fasting glucose > 100 mg/dl < 126 mg/dl or 2 hour glucose from OGTT > 140 mg/dl but less than 200 mg/dl
  • Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT

Exclusion Criteria:

  • Clinically significant CVD including h/o MI
  • Peripheral Vascular Disease
  • Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
  • Clinically diminished pulse
  • Presence of bruits in lower extremities
  • Previous history of pulmonary emboli
  • Peripheral Neuropathy
  • Currently not engaged in a regular program and have a V)2 max pre-training value > 55 ml/kg-fat free mass-min., indicative of moderate fitness OR currently engaged in regular program and having a V)2 max value < 55 ml/kg-fat free mass-min.
  • Anemia (Hematocrit < 34%)
  • Any contraindications to moderate exercise
  • Inability and/or willingness to comply with the protocol as written
  • Active alcohol or substance abuse (Past 5 years)
  • Total cholesterol > 300 mg/dL
  • Triglyceride > 350 mg/dL
  • ALT > 80, AST > 80, Alk Phos > 240
  • Proteinuria (defined as > 1+ on routine dipstick) hypothyroidism (sTSH>8)
  • Therapeutic Doses of Nicotinic Acid
  • Type 2 Diabetes: Fasting Glucose > 126 mg/dl or 2 hour glucose > 200 mg/dl
  • Oral Glucocorticoids
  • Females currently on hormone replacement therapy (HRT) less than 6 months
  • Claustrophobia
  • Previous difficulty with lidocaine or other local anesthetic

  • Stress test symptoms:

    • Positive ECG (>2mm ST segment depression) without PCP cardiologist permission to participate
    • Signs or symptoms of cardiovascular decomposition (hypotensive response to exercise
    • Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness
    • Hypotension

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

Health Education Group

Arm Description

Exercise Group

Outcomes

Primary Outcome Measures

Insulin sensitivity and muscle fat content will be measured at the beginning and the end of the intervention to determine the effects of exercise on these measures.

Secondary Outcome Measures

Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.

Full Information

First Posted
October 2, 2008
Last Updated
February 3, 2018
Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00765505
Brief Title
Muscle Lipid and Insulin Resistance in the Elderly
Acronym
MIRA
Official Title
Muscle Lipid and Insulin Resistance in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project will provide novel information concerning the ability of exercise to enhance the capacity for oxidative metabolism of fatty acids and improve insulin resistance in older adults who are at high risk for the development of type 2 diabetes. Ultimately this may help identify mechanisms and therapeutic targets implicated in skeletal muscle metabolic dysregulation. The proposed study is to conduct a randomized controlled exercise training intervention trial in older men and women. In addition, the response to exercise in these subjects will be compared to those of highly endurance-trained, age-matched athletes.
Detailed Description
Hypothesis and Specific Aims: To determine whether aerobic exercise improves both skeletal muscle fat distribution and insulin sensitivity of older men and women. We will test two hypotheses. i. Physical exercise in older adults will decrease the amount of fat interspersed within muscle, specifically the fat between muscle groups (intermuscular adipose tissue) as well as decrease specific lipid metabolites within muscle cells, compared to controls. ii. Exercise-induced improvements in insulin sensitivity of older men and women will be related to the changes in muscle fat content independent of changes in total body fat or visceral abdominal adipose tissue. To determine whether increased capacity for oxidative fatty acid metabolism within muscle results in improved insulin sensitivity in older adults. We will test two hypotheses. i. Exercise training will increase the capacity of muscle to oxidize fatty acids assessed both in vitro and in vivo. ii. Improved capacity for oxidative fatty acid metabolism will predict improvements in insulin sensitivity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Insulin Resistance, Obesity, Exercise Training, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Exercise Group
Arm Title
Health Education Group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise Group
Intervention Description
Sixteen week intervention where subjects will be progressed to four days per week for 45 minutes per session, 180 minutes minimum per week, of moderate intensity supervised exercise.
Intervention Type
Behavioral
Intervention Name(s)
Health Education Group
Intervention Description
Sixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions
Primary Outcome Measure Information:
Title
Insulin sensitivity and muscle fat content will be measured at the beginning and the end of the intervention to determine the effects of exercise on these measures.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 - 70 years of age No weight gain/loss of >10 lbs in 6 months Sedentary (No more than 1 continuous exercise/week) or Highly trained (>5 exercise sessions/week for a duration of one year or more) Non-Smoker BMI 18-38.0 Resting blood pressure less than 150mmHg systolic/95 mmHg diastolic Normal glucose tolerance: Fasting glucose < 100 mg/dl or 2 hour glucose from OGTT < 140 mg/dl or impaired glucose tolerance (fasting glucose > 100 mg/dl < 126 mg/dl or 2 hour glucose from OGTT > 140 mg/dl but less than 200 mg/dl Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT Exclusion Criteria: Clinically significant CVD including h/o MI Peripheral Vascular Disease Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease Clinically diminished pulse Presence of bruits in lower extremities Previous history of pulmonary emboli Peripheral Neuropathy Currently not engaged in a regular program and have a V)2 max pre-training value > 55 ml/kg-fat free mass-min., indicative of moderate fitness OR currently engaged in regular program and having a V)2 max value < 55 ml/kg-fat free mass-min. Anemia (Hematocrit < 34%) Any contraindications to moderate exercise Inability and/or willingness to comply with the protocol as written Active alcohol or substance abuse (Past 5 years) Total cholesterol > 300 mg/dL Triglyceride > 350 mg/dL ALT > 80, AST > 80, Alk Phos > 240 Proteinuria (defined as > 1+ on routine dipstick) hypothyroidism (sTSH>8) Therapeutic Doses of Nicotinic Acid Type 2 Diabetes: Fasting Glucose > 126 mg/dl or 2 hour glucose > 200 mg/dl Oral Glucocorticoids Females currently on hormone replacement therapy (HRT) less than 6 months Claustrophobia Previous difficulty with lidocaine or other local anesthetic Stress test symptoms: Positive ECG (>2mm ST segment depression) without PCP cardiologist permission to participate Signs or symptoms of cardiovascular decomposition (hypotensive response to exercise Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness Hypotension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bret H. Goodpaster, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Muscle Lipid and Insulin Resistance in the Elderly

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