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Upper body obesity for Obesity

Phase < 1
Recruiting
Led By Michael Jensen, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females between 18 and 65 years of age who are able to comprehend instructions, follow study procedures, willing to sign an informed consent form, and consume an isoenergetic diet eating all meals from Mayo CRTU for at least 3 days prior to study
Upper body obesity criteria for men
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx. 6 hours
Awards & highlights

Study Summary

This trial is studying why people who gain weight in their belly often don't respond to weight loss methods like those who are leaner.

Who is the study for?
This study is for men and women aged 18-65 who are overweight or obese, with a BMI of 29.0 - 40.0 kg/m2, especially those carrying extra weight around their abdomen. Participants must not have heart disease, high blood pressure that's uncontrolled by medication, be smokers, or take drugs affecting fat metabolism. They should also not be allergic to lidocaine or Niaspan.Check my eligibility
What is being tested?
The trial is investigating how niacin affects fat tissue in people with different body types, particularly focusing on adults who carry excess abdominal weight and may react differently to factors that usually 'turn off' fat cells.See study design
What are the potential side effects?
While the side effects of niacin are not detailed here, common ones include skin flushing or redness, itching or tingling sensations, digestive upset like nausea or indigestion, and increased blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old, can follow instructions, and am willing to eat specific meals for 3 days before the study.
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I am a man with most of my body fat around my waist.
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My BMI is between 29.0 and 40.0.
Select...
I am a woman with upper body or visceral obesity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx. 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and approx. 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in plasma free fatty acid (FFA) concentrations
Secondary outcome measures
pHSL/HSL response

Side effects data

From 2008 Phase 4 trial • 30 Patients • NCT00203476
50%
Flushing
10%
Loose Stools
10%
Elevated LFTs
100%
80%
60%
40%
20%
0%
Study treatment Arm
Niacin
Colestipol
Ezetimibe

Trial Design

2Treatment groups
Experimental Treatment
Group I: Upper body obesityExperimental Treatment1 Intervention
Subjects identify with upper body obesity will receive Niacin to lean how fat cells in different regions of the body the response.
Group II: Normal weightExperimental Treatment1 Intervention
Subjects identify with normal body weight will receive Niacin to lean how fat cells in different regions of the body the response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niacin
2008
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,216 Previous Clinical Trials
3,767,456 Total Patients Enrolled
85 Trials studying Obesity
14,723 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,560 Total Patients Enrolled
447 Trials studying Obesity
588,938 Patients Enrolled for Obesity
Michael Jensen, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I qualify for enrollment in this experimental procedure?

"To qualify for the trial, patients must have obesity and be between 18 to 65 years old. Currently, 32 participants are accepted into this research project."

Answered by AI

Does the study extend its eligibility to individuals aged 70 and above?

"This research requires volunteers aged between 18 years and 65 years."

Answered by AI

Is this program currently enrolling new participants?

"According to clinicaltrials.gov, this specific medical trial is no longer recruiting participants; the study was posted on December 1st 2023 and updated as recently as 7th of that same month. However, there are more than sixty additional trials actively seeking candidates at this present moment in time."

Answered by AI
~21 spots leftby May 2027