Understanding how insulin affects fat release in people with obesity
Insulin Regulation of Regional Lipolysis
This study tests how insulin affects fat release in people with obesity compared to those without, to better understand why insulin works differently in those with more abdominal fat.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06392854 on ClinicalTrials.gov |
What this trial studies
This study investigates the differences in insulin response and fat tissue behavior in adults with upper body obesity compared to those without. Participants will undergo measurements of regional free fatty acid release under various conditions that either suppress or stimulate lipolysis. The study aims to uncover the mechanisms behind the altered insulin regulation in individuals with obesity, particularly focusing on abdominal fat distribution. Volunteers will follow a controlled diet provided by the Mayo Clinic for three days prior to the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a BMI between 29.0 and 37.0 kg/m2, particularly those with upper body obesity.
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 and related metabolic disorders.
How similar studies have performed: Other studies have explored insulin regulation in obesity, but this specific approach focusing on regional fat response is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males and females 18-65years who are able to comprehend instructions, follow study procedures and who willing to provide written, informed consent will be included. The volunteers will consume an isoenergetic diet eating all meals from Mayo Clinical Research Trials Unit (CRTU) for 3 days prior to study. * Overweight/Obese volunteers will have a BMI 29.0 - 37.0 kg/m2 * 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 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 \> 180 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 adenosine triphosphate (ATP) III criteria. These visceral fat values are based upon the data collected at Mayo Clinic using our methods, and are correlated with dyslipidemia and hyperinsulinemia. * Lower body obesity (LBO) in women will be defined as a waist-hip ratio of \<0.75 and/or a lower visceral fat by single slice CT scan, usually \< 120 cm2 or a visceral fat/total fat ratio of ≤ 0.30 and fasting plasma triglycerides within the normal range. The term "lower body men" is used to describe a male phenotype that is characteristic of adipose insulin sensitivity even with excess body fat. A waist to hip ratio isn't suitable for this description as it is for women. LBO men will be defined as obese men with normal fasting plasma triglycerides, normal fasting plasma glucose and greater proportional leg fat via dual-energy x-ray absorptiometry (DEXA). * 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 day of admission for inpatient study visit. 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 * Smokers * Diagnosis Diabetes Mellitus * Concomitant use of medications that can alter free fatty acid metabolism, including, but not limited to niacin, thiazolidinediones, beta-blockers, oral or injected corticosteroids or anabolic steroids. * 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.