## Protocol Section
### Identification Module
**NCT ID:** NCT06416969

**Brief Title:** Regional Lipolysis and Adipocyte Lipolysis Protein Stimulation

**Official Title:** Stimulation of Regional Lipolysis and Adipocyte Lipolysis Proteins

#### Organization Study ID Info
**ID:** 23-004069
#### Organization
**Class:** OTHER
**Full Name:** Mayo Clinic
#### Secondary ID Infos
**ID:** R01DK040484
**Link:** https://reporter.nih.gov/quickSearch/R01DK040484
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-01
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

#### Lead Sponsor

**Class:** OTHER

**Name:** Mayo Clinic

#### Responsible Party

**Investigator Affiliation:** Mayo Clinic

**Investigator Full Name:** Michael D. Jensen

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Obesity

### Design Module

#### Design Info

**Allocation:** NON_RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 24

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects that have upper body obesity will receive somatostatin plus epinephrine

**Intervention Names:**

- Drug: Somatostatin

- Drug: Epinephrin

**Label:** Obesity Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subject wo are normal weight will receive somatostatin plus epinephrine

**Intervention Names:**

- Drug: Somatostatin

- Drug: Epinephrin

**Label:** Lean Group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lean Group

- Obesity Group

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

**Name:** Somatostatin

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Lean Group

- Obesity Group

**Description:** Intravenous infusion

**Name:** Epinephrin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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 somatostatin plus epinephrine. This will allow us to understand the factors that may limit maximum lipolysis stimulation in upper body obesity for leg, splanchnic and upper body non-splanchnic adipose tissue palmitate release.

**Measure:** Free Fatty Acid (FFA) release from femoral, splanchnic and upper body subcutaneous adipose tissue

**Time Frame:** approximately 2.5 hours

### Eligibility Module

**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:
* HbA1C \< 6.5% for non-diabetic UBO
* 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; thiazolidinediones; Beta-blockers; Oral or injected corticosteroids or anabolic steroids; Any history of use of pioglitazone; Linezolid; Dihydroergotamine; Phenelzine; Phosphodiesterase inhibitors
* Allergy to lidocaine
* Allergy to indocyanine green.

**Gender Based:** True

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** reich.pamela@mayo.edu

**Name:** Pamela Reich

**Phone:** (507) 255-6062

**Role:** CONTACT

**Contact 2:**

**Email:** lytle.kelli@mayo.edu

**Name:** Kelli Lytle, PhD

**Phone:** (507) 255-1488

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rochester

**Contacts:**

***Contact 1:***

- **Email:** reich.pamela@mayo.edu

- **Name:** Pamela A. Reich

- **Phone:** 507-255-6062

- **Role:** CONTACT

***Contact 2:***

- **Email:** lytle.kelli@mayo.edu

- **Name:** Kelli A Lytle, PhD

- **Phone:** (507) 255-1488

- **Role:** CONTACT

**Country:** United States

**Facility:** Mayo Clinic in Rochester

**State:** Minnesota

**Zip:** 55905

#### Overall Officials

**Official 1:**

**Affiliation:** Mayo Clinic

**Name:** Michael Jensen, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000318

- Term: Adrenergic beta-Agonists

- ID: D000001993

- Term: Bronchodilator Agents

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000018927

- Term: Anti-Asthmatic Agents

- ID: D000019141

- Term: Respiratory System Agents

- ID: D000009184

- Term: Mydriatics

- ID: D000013566

- Term: Sympathomimetics

- ID: D000014662

- Term: Vasoconstrictor Agents

- ID: D000006728

- Term: Hormones

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7992

- Name: Epinephrine

- Relevance: HIGH

- As Found: Growth

- ID: M15806

- Name: Somatostatin

- Relevance: HIGH

- As Found: During exercise

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3670

- Name: Adrenergic beta-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M5269

- Name: Bronchodilator Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20963

- Name: Anti-Asthmatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

- ID: M12139

- Name: Mydriatics

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004837

- Term: Epinephrine

- ID: D000013004

- Term: Somatostatin

### Misc Info Module

- Version Holder: 2024-05-31
