Regional Lipolysis Insulin Regulation Study for Obesity

This study is looking at how fat tissue in the body responds to insulin in adults with obesity, especially those who carry extra weight around their belly. Researchers want to understand why fat cells might react differently to insulin depending on a person's body type. You might be able to join if you are between 18 and 65 years old, have a BMI (Body Mass Index) between 29.0 and 37, and are able to follow study instructions. The study will involve receiving two different doses of insulin for four hours. The main goal is to measure how much palmitate (a type of fat) is released from your body, which will be measured during a single 6-hour study day. The current status of this study is unclear, and it plans to enroll 48 participants.

Study design: This is an interventional study planning to enroll 48 participants. The phase of the study is not specified.
What's involved: You would consume all meals from the Mayo Clinical Research Trials Unit for 3 days before the study. The study itself will take place on a single day and last approximately 6 hours, involving a 2-dose insulin infusion.
Compensation: Not stated in the trial record.
Follow-up: Palmitate release will be measured on the single study day, which lasts approximately 6 hours. No further follow-up is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Regional Lipolysis Insulin Regulation

Recruiting

EARLY_PHASE1Ages 18–65InterventionalBasic science

Mayo Clinic

~48 participants

Updated 2026-04-13 on ClinicalTrials.gov

What's tested:Insulin

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

palmitate release

Measured over The study will be conducted in a single day and will last approximately 6 hours

Conditions

Obesity

Where it's being run

1 sites across 1 states

Minnesota1

Study leadership

Michael Jensen, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Madeline S Reid

[email protected]

507-255-0007

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

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

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.

What this trial measures

palmitate releaseThe study will be conducted in a single day and will last approximately 6 hours
regional palmitate release rates (micromol/min) will be measured using a combination of leg and splanchnic blood flow combined with stable isotope tracer measurements of palmitate uptake and release across the leg and splanchnic bed. Upper body, non-splanchnic palmitate release will be calculated as: total palmitate release - (splanchnic palmitate release + (leg palmitate release x 2)). Release rates will be measured at baseline (overnight fasting) and in response to the infusion of insulin at low and medium rates. This will allow us to create dose-response curves for leg, splanchnic and upper body non-splanchnic adipose tissue palmitate release.

Trialytics