Understanding fat cell response in abdominal obesity

Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins

This study is testing how fat cells in people with abdominal obesity react to certain treatments compared to those without extra weight to better understand why their fat cells behave differently.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT06416969 on ClinicalTrials.gov

What this trial studies

This study investigates how fat tissue in individuals with abdominal obesity responds differently to stimuli compared to those without excessive weight. It involves administering interventions such as somatostatin and epinephrine to analyze their effects on lipolysis in adipocytes. Participants will follow a controlled isoenergetic diet for at least three days prior to the interventions to ensure consistency in dietary intake. The goal is to uncover the mechanisms behind the altered fat cell responses in overweight and obese individuals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 29.0 and 40.0 kg/m2 and upper body obesity characteristics.

Not a fit: Patients who are not overweight or obese, or those outside the specified age range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatments for obesity by targeting specific fat cell responses.

How similar studies have performed: While there have been studies on fat cell responses, this specific approach focusing on abdominal obesity and the use of somatostatin and epinephrine is relatively novel.

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.

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Michael Jensen, MD — Mayo Clinic
• Study coordinator: Madeline Reid

Conditions Obesity