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Behavioral Intervention
Obesogenic Lifestyle for Insulin Resistance
N/A
Recruiting
Research Sponsored by University of New Hampshire
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
Study Summary
This trial aims to learn how an obesogenic lifestyle affects insulin resistance and metabolic flexibility in fit young men.
Who is the study for?
This trial is for fit young men aged 18-26 who exercise moderately to vigorously at least two days a week. They should have good cardio fitness but can't join if they have diabetes, high fasting blood sugar, high blood pressure, heart disease, cancer, chronic kidney disease or any musculoskeletal issues that stop them from biking.Check my eligibility
What is being tested?
The study looks at how an obesogenic lifestyle with extra carbs affects insulin resistance and the body's ability to use fats and carbs in active young men. Participants will be split into two groups: one adopting this new lifestyle and the other remaining sedentary as a control.See study design
What are the potential side effects?
Since this isn't testing a drug but rather lifestyle changes, side effects might include weight gain, increased body fat percentage, decreased physical fitness levels and potential development of metabolic disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine if an obesogenic model leads to impaired 24-hour glucose regulation compared to sedentary controls.
To determine if fat oxidation is impaired following an obesogenic lifestyle model
To determine if sedentary activity alone contributes to insulin resistance in healthy, recreationally active young men compared to an obesogenic model.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Obesogenic Lifestyle Model GroupExperimental Treatment1 Intervention
10-days of sedentary activity (~5,000 steps/day) while consuming added sugar-sweetened beverages (250g/day).
Group II: Normal Activity ControlActive Control1 Intervention
Maintains normal physical activity levels and exercise training
Group III: Sedentary ControlPlacebo Group1 Intervention
10-days of sedentary activity (~5,000 steps/day).
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Who is running the clinical trial?
University of New HampshireLead Sponsor
14 Previous Clinical Trials
105,394 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Men between the ages of 18 and 26.You have been told by a doctor that you have diabetes.You have good heart and lung fitness (VO2>38.6 ml/kg/min).Your blood sugar levels when you haven't eaten are higher than 100mg/dL.You exercise for 75-150 minutes at a moderate to vigorous level for at least 2 days a week.You have a known heart or blood vessel condition.You have been diagnosed with long-term kidney disease.You have high blood pressure.You have been diagnosed with cancer.You have a condition that stops you from riding a bike due to problems with your muscles or bones.
Research Study Groups:
This trial has the following groups:- Group 1: Obesogenic Lifestyle Model Group
- Group 2: Sedentary Control
- Group 3: Normal Activity Control
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any fresh participants being sought for the study?
"Affirmative. Clinicaltrials.gov data shows that this clinical trial, which was initially uploaded on February 8th 2023, is actively recruiting patients for participation. 34 individuals must be recruited from a single site to fulfill the study's requirements."
Answered by AI
What is the upper limit of study participants engaging in this research?
"Affirmative. According to information available on clinicaltrials.gov, this medical trial is currently seeking participants. The initial posting was made on February 8th 2023 and it has since been updated as recently as June 12th 2023. This research requires 34 patients at a single location for proper data gathering."
Answered by AI
Would I be eligible to join this research project?
"To qualify for this experiment, volunteers must suffer from insulin resistance and be between 18-26 years old. In total, 34 participants are required for the study to reach completion."
Answered by AI
Does this trial include geriatric participants?
"As per the rules of this medical trial, prospective participants have to be aged 18 - 26."
Answered by AI
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