Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
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• 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

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Pamela Reich
reich.pamela@mayo.edu
(507) 255-6062
Backup
Kelli Lytle, PhD
lytle.kelli@mayo.edu
(507) 255-1488
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 24
Treatments
Experimental: Obesity Group
Subjects that have upper body obesity will receive somatostatin plus epinephrine
Experimental: Lean Group
Subject wo are normal weight will receive somatostatin plus epinephrine
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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