ObesityMIRANCT00765505
Muscle Lipid and Insulin Resistance in the Elderly
A study testing Exercise Group and Health Education Group in people with Obesity, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Exercise Group and Health Education Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- 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.
- 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.
- Conditions
- Obesity
- Being tested
- Exercise Group, Health Education Group
- Keywords
- Insulin Resistance, Obesity, Exercise Training, Physical Activity
- Medical subject headings
- Obesity, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise GroupBehavioural
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.
Health Education GroupBehavioural
Sixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise Group Receives: Behavioral: Exercise Group |
| Health Education Group | Experimental | Not described Receives: Behavioral: Health Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (1)
Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2008 (estimated)
- Study startJul 2004
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Erin E. Kershaw, M.D., University of Pittsburgh
- Investigators
- Bret H. Goodpaster, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765505
- Sponsor's protocol ID
- 0405764
- Other IDs
- 5R01AG021961
- Acronym
- MIRA
- Status last verified
- Feb 2018
- First submitted
- 2 Oct 2008
- Last updated
- 6 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Lipid and Insulin Resistance in the Elderly
- ClinicalTrials.gov ID
- NCT00765505
- Acronym / sponsor ID
- MIRA / 0405764
- Conditions
- Obesity
- Keywords
- Insulin Resistance, Obesity, Exercise Training, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2004
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Exercise GroupExercise Group |
| Health Education Group | Experimental | Behavioral: Health Education Group |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise GroupSixteen 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. | Behavioural | 1 |
| Health Education GroupSixteen week intervention. This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions | Behavioural | Health Education Group |
Primary outcome
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
1 secondary outcome
Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bret H. Goodpaster, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Group and Health Education Group in people with Obesity, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2018.