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Exercise Training for Fat Metabolism in Postmenopausal Women
N/A
Recruiting
Led By Michael J Ormsbee, PhD
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prediabetes (HbA1c 5.7 - 6.4% or fasting blood glucose 100 to 125 mg/dL, or 2hr OGTT blood glucose 140 to 199 mg/dL)
Postmenopausal (50-70 yrs.)
Must not have
Musculoskeletal disease or injury that would otherwise prevent engagement in resistance and endurance training
Taking any medication affecting lipid metabolism
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks of resistance or endurance training
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how well resistance training improves fat metabolism in postmenopausal women with obesity and pre-diabetes, to see if it could help prevent type 2 diabetes.
Who is the study for?
This trial is for postmenopausal women aged 50-70, who are obese with a BMI of 30-39.9 and have prediabetes. They should not be smokers or currently on hormone replacement therapy, and must be relatively inactive (not exercising more than twice a week). Women with certain medical conditions or taking medications affecting fat metabolism cannot participate.
What is being tested?
The study aims to compare the effects of resistance exercise versus endurance exercise on fat metabolism in postmenopausal women at risk for type 2 diabetes. It will assess how these exercises can influence body weight maintenance by altering the balance between fat breakdown and synthesis.
What are the potential side effects?
While specific side effects are not listed, typical risks associated with physical activity may include muscle soreness, fatigue, joint stress, and increased heart rate during exercise. Participants will likely be monitored for any adverse reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood sugar levels indicate I have prediabetes.
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I am a woman aged 50-70 and have gone through menopause.
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My BMI is between 30 and 39.9, indicating obesity.
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I am a woman aged 50-70 and have gone through menopause.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition or injury that stops me from doing physical exercises like lifting weights or running.
Select...
I am taking medication that affects fat processing in my body.
Select...
My thyroid, liver, and kidneys are functioning normally.
Select...
I have diabetes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks of resistance or endurance training
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks of resistance or endurance training
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline gluteal adipose tissue glycerol concentration at 12 weeks
Change from baseline subcutaneous abdominal adipose tissue glycerol concentration at 12 weeks
Change from baseline whole-body lipolysis at 12 weeks
Secondary study objectives
Change in adipogenesis
Change in blood flow as measured by ethanol concentrations in dialysate samples from subcutaneous abdominal adipose tissue
Change in blood growth hormone concentrations
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Resistance ExerciseExperimental Treatment1 Intervention
Participants do regular resistance exercise for 12 weeks.
Group II: Endurance ExerciseExperimental Treatment1 Intervention
Participants do regular endurance exercise for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Endurance Exercise
2012
N/A
~160
Resistance Exercise
2010
Completed Phase 4
~920
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
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36,335 Total Patients Enrolled
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
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Pennington Biomedical Research CenterOTHER
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You smoke or have been diagnosed with an eating disorder.I have a condition or injury that stops me from doing physical exercises like lifting weights or running.I am a woman.My blood sugar levels indicate I have prediabetes.I am taking medication that affects fat processing in my body.Your blood pressure when you are not moving around is higher than 140 over 90.You do not smoke cigarettes.I am a woman aged 50-70 and have gone through menopause.My thyroid, liver, and kidneys are functioning normally.I haven't used hormone replacement therapy in the last two years.I have or had cancer, heart, or lung disease.You don't regularly exercise for at least 20 minutes, twice a week.My BMI is between 30 and 39.9, indicating obesity.You regularly do intense workouts for more than 20 minutes at a time, at least 2 days a week.I have diabetes.I am a woman aged 50-70 and have gone through menopause.
Research Study Groups:
This trial has the following groups:- Group 1: Resistance Exercise
- Group 2: Endurance Exercise
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.
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