Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

NCT ID: NCT06416969

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2027-04-01

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Obesity Group

Subjects that have upper body obesity will receive somatostatin plus epinephrine

Group Type: EXPERIMENTAL

Somatostatin

Intervention Type: DRUG

Intravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes

Epinephrine

Intervention Type: DRUG

Intravenous infusion

Lean Group

Subject wo are normal weight will receive somatostatin plus epinephrine

Group Type: EXPERIMENTAL

Somatostatin

Intervention Type: DRUG

Intravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes

Epinephrine

Intervention Type: DRUG

Intravenous infusion

Interventions

Somatostatin

Intravenous infusion 200 ug/hr for 2 hours, 100 ug/hr for 30 minutes

Intervention Type: DRUG

Epinephrine

Intravenous infusion

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Michael D. Jensen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Madeline Reid

Role: CONTACT

Phone: (507) 255-6062

Email: reid.madeline@mayo.edu

Kelli Lytle, PhD

Role: CONTACT

Phone: (507) 255-1488

Email: lytle.kelli@mayo.edu

Facility Contacts

Madeline Reid

Role: primary

Kelli A Lytle, PhD

Role: backup

Other Identifiers

R01DK040484

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-004069

Identifier Type: -

Identifier Source: org_study_id