Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

Launched by MAYO CLINIC · May 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how fat cells in people who are overweight or obese, especially those with extra weight around their stomachs, respond to treatments aimed at reducing fat. Researchers want to understand why these fat cells behave differently compared to those in people with a healthier weight. This knowledge could help develop better treatments for obesity.

To participate in this study, you must be an adult between 18 and 65 years old with a body mass index (BMI) of 29 to 40, which indicates you're overweight or obese. You should also be able to follow instructions and be willing to eat specific meals provided by the research team for at least three days before the study starts. Participants will not have severe health issues like heart disease or diabetes and must not be pregnant or nursing. If you join the study, you can expect to follow a structured diet and be closely monitored by the research team. It's important to note that this trial is currently recruiting participants, so if you meet the criteria and are interested, you could contribute to important research on obesity.

Gender

ALL

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 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.

Trial Officials