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Weight Loss + Exercise for Aging-related Inflammation (ALIVE Trial)
N/A
Waitlist Available
Led By Jacob B Blumenthal, MD
Research Sponsored by University of Maryland, College Park
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All women over the age of 50 must be postmenopausal for at least 1 year, have serum FSH >30 mIU/ml, and agree to remain off hormone replacement therapy for the duration of the study
Be older than 18 years old
Must not have
HIV (+) or other disease prone to malnutrition
Sickle cell anemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is for people who are overweight and want to improve their health. You may lose a moderate amount of weight and increase your activity, which can improve health by reducing inflammation.
Who is the study for?
This study is for veterans who are overweight with a waist size of 80-120cm for men or 70-110cm for women, have a stable medical regimen, and BMI between 20-40. Women over 50 must be postmenopausal. Participants should not smoke, have certain chronic diseases, uncontrolled hypertension, recent significant weight changes, or use medications affecting metabolism.
What is being tested?
The trial aims to see if losing some weight and doing more aerobic exercise can reduce inflammation in the body. It's looking at how age and body fat affect the production of inflammatory chemicals and whether these lifestyle changes can improve health outcomes related to being overweight.
What are the potential side effects?
While specific side effects aren't listed for this lifestyle intervention trial involving weight loss and exercise, participants may experience muscle soreness, fatigue or injury from increased physical activity. Any other adverse effects will likely be monitored by the research team.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman over 50, postmenopausal for 1+ year, and not on hormone therapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am HIV positive or have a condition that could lead to malnutrition.
Select...
I have sickle cell anemia.
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I need oxygen therapy for my lung condition.
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I cannot exercise due to heart or brain blood vessel issues.
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I need more than 3 medications or beta blockers to manage my high blood pressure.
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My weight has changed by more than 5kg in the last 3 months.
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I have a long-term liver, kidney, or blood disease.
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I am currently receiving radiation or chemotherapy for my cancer.
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I have long-term depression that I haven't treated.
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I have had a stroke that affects one side of my body.
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I have diabetes and am on medication, or my fasting blood sugar is over 126 mg/dl.
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I have high cholesterol or triglycerides, or I'm taking Lipitor or Crestor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lifestyle ModificationExperimental Treatment1 Intervention
Combined hypocaloric diet and aerobic exercise training
Find a Location
Who is running the clinical trial?
University of Maryland, College ParkLead Sponsor
158 Previous Clinical Trials
46,268 Total Patients Enrolled
5 Trials studying Aging
506 Patients Enrolled for Aging
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,392 Total Patients Enrolled
5 Trials studying Aging
191 Patients Enrolled for Aging
US Department of Veterans AffairsFED
873 Previous Clinical Trials
497,741 Total Patients Enrolled
11 Trials studying Aging
1,976 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need more than 3 medications or beta blockers to manage my high blood pressure.My weight has changed by more than 5kg in the last 3 months.I have a long-term liver, kidney, or blood disease.I am a woman over 50, postmenopausal for 1+ year, and not on hormone therapy.I am HIV positive or have a condition that could lead to malnutrition.I have sickle cell anemia.I have a thyroid condition.I need oxygen therapy for my lung condition.I cannot exercise due to heart or brain blood vessel issues.I am currently receiving radiation or chemotherapy for my cancer.I have long-term depression that I haven't treated.I have a health condition that prevents me from doing exercise or joining weight loss programs.I have had a stroke that affects one side of my body.I have diabetes and am on medication, or my fasting blood sugar is over 126 mg/dl.I have high cholesterol or triglycerides, or I'm taking Lipitor or Crestor.My current medications have been the same for at least 30 days.I am not on medications that affect my blood sugar, fats, or inflammation markers.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle Modification
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aging Patient Testimony for trial: Trial Name: NCT00667030 — N/A
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