No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
24 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who are overweight or obese, especially with extra weight around the abdomen. Participants will follow a specific diet and take part in research to understand how body fat works differently in various people.
Are You a Good Fit for This Trial?
Must not be takingStatinsNiacinFibratesThiazolidinedioneBeta-blockersCorticosteroids
Rules you outIschemic heart diseaseCoronary artery diseasePeripheral artery disease
You may be able to join if
I am between 18 and 65 years old.
I can understand instructions and follow study procedures.
I am willing to sign a consent form.
I will eat a specific diet provided by the study for at least 3 days.
I have a BMI between 29.0 and 40.0.
I have a waist-hip ratio greater than 0.85 (for women) or 0.95 (for men), or meet other criteria for abdominal obesity.
You may not be able to join if
I have had a heart attack or stroke.
I have uncontrolled high blood pressure.
I have liver cirrhosis or severe kidney issues.
I smoke.
I have diabetes.
I am allergic to lidocaine or indocyanine green.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Adults who gain most of their excess weight in the abdominal area typically do not respond to factors that "turn on" fat cells the same way as people who don't have excessive weight. Researchers are trying to understand why fat tissue responds differently in people with different body types.
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Eligibility Criteria
Inclusion Criteria:
* 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 Clinical Research and Trials Unit for at least 3 days prior …
Inclusion Criteria:
* 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 Clinical Research and Trials Unit for at least 3 days prior to study.
* Overweight/Obese volunteers will have a BMI 29.0 - 40.0 kg/m2
o Upper body/visceral obesity (UBO) in women will be defined as those with a waist-hip ratio (WHR) \> 0.85 and/or increased visceral fat by single slice CT scan, usually with \> 120 cm2 of visceral fat by CT scanning or a visceral fat/total fat ratio of \> 0.30, and/or biochemical evidence of metabolic syndrome as defined by adenosine triphosphate (ATP) III criteria (fasting plasma triglycerides ≥ 150 mg/dL, HDL-cholesterol \< 50 mg/dL for women and \< 40 mg/dL for men, fasting plasma glucose ≥ 100 mg/dL). Upper body obesity in men will be defined as a waist-hip ratio of \>0.95 and/or increased visceral fat (visceral fat area \> 120 cm2 or a visceral/total fat abdominal ratio by CT of \> 0.40) by single slice CT scan and/or biochemical evidence of metabolic syndrome as defined by ATP III criterial. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia.
* Female subjects are eligible if they meet the following criteria:
* Are not pregnant or nursing
* All women of childbearing potential will have a negative urine pregnancy test at screening and a negative urine pregnancy test within 48 hours before administering study drug.
* Recent or current research participation in a study that involves an investigational drug. Participants in other clinical trials that involve an investigational drug will not be able to participate in this study until 12 weeks after their participation in the other study is complete or \> than five half-lives of the compound, whichever is longer. If Yes look at consent form and f/u visits:
* Current use of medications that alter fatty acid or adipose metabolism possibly given: if yes, exclude
* Amount of blood drawn during the study (if our study plus this one draw ≥ 450 ml these should be separated by 8 weeks
* Previous labs:
* Fasting glucose \< 126 mg/dl for non-diabetic UBO
* Hb ≥ 11.0 for women and ≥ 12 for men
* platelets \> 100 000
Exclusion Criteria:
* Individuals with a history of a disease process such as:
* Ischemic heart disease
* Atherosclerotic valvular disease
* Persistent blood pressure greater than 160/95 despite antihypertensive medication
* Peripheral artery disease
* Any history of trans-ischemic attacks.
* Coronary artery disease.
* Liver cirrhosis
* Significant renal impairment as documented in medical chart.
* Smokers
* Diagnosis of Diabetes Mellitus.
* Concomitant use of medications that can alter free fatty acid metabolism or pose a drug-drug interaction: statins (if yes hold for 4 weeks and receive primary care provider's approval); Niacin; Fibrates; thiazolidinedione; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Linezolid; Dihydroergotamine; Phenelzine; daily phosphodiesterase inhibitors
* Allergy to lidocaine
* Allergy to indocyanine green.
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