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Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Primary Purpose

Obesity, Morbid

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Gastric sleeve/bariatric surgery

About this trial

This is an interventional basic science trial for Obesity, Morbid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

BMI 40 - 50 kg/m2.
Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery

Exclusion Criteria:

Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
Active coronary artery disease
Participation in structured exercise (>2 times per week for 30 minutes or longer)
Smoking
Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
Renal insufficiency (serum creatinine > 1.5mg/dl)
Chronic active liver disease (Bilirubin > 17mmol/L, AST > 144 IU/L, or ALT>165IU/L)
Pregnancy or breastfeeding.

Sites / Locations

Mayo ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gastric sleeve surgery

Arm Description

before and after weight loss from bariatric surgery

Outcomes

Primary Outcome Measures

Long-term, substantial weight loss and insulin regulation of lipolysis

Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue inflammation as measured by: 1) changes in the number of pro-inflammatory (CD14+) macrophages; 2) adipose tissue content of IL-6 and TNF

Long-term, substantial weight loss and insulin regulation of lipolysis

Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by: 1) changes in adipocyte perilipin 1 and FSP27 relative to HSL and ATGL; 2) changes in adipocyte G0S2 relative to ATGL; 3) changes in adipocyte CGI-58 relative to ATGL; 4) changes in dephosphorylation of adipocyte perilipin 1, ATGL and HSL in response to insulin.

Secondary Outcome Measures

Full Information

NCT ID

NCT03868592

First Posted

March 7, 2019

Last Updated

December 6, 2022

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT03868592

Brief Title

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Official Title

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Morbid

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Study insulin action and adipose function before and after weight loss from gastric sleeve surgery

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastric sleeve surgery

Arm Type

Experimental

Arm Description

before and after weight loss from bariatric surgery

Intervention Type

Procedure

Intervention Name(s)

Gastric sleeve/bariatric surgery

Intervention Description

weight loss

Primary Outcome Measure Information:

Title

Long-term, substantial weight loss and insulin regulation of lipolysis

Description

Time Frame

1 year

Title

Long-term, substantial weight loss and insulin regulation of lipolysis

Description

Patients will undergo studies of insulin regulation of FFA release combined with adipose biopsies before and one year after bariatric surgery (gastric sleeve). We will relate the improvement in insulin-regulation of lipolysis to changes in adipose tissue lipolysis proteins as measured by: 1) changes in adipocyte perilipin 1 and FSP27 relative to HSL and ATGL; 2) changes in adipocyte G0S2 relative to ATGL; 3) changes in adipocyte CGI-58 relative to ATGL; 4) changes in dephosphorylation of adipocyte perilipin 1, ATGL and HSL in response to insulin.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: BMI 40 - 50 kg/m2. Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery Exclusion Criteria: Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL Active coronary artery disease Participation in structured exercise (>2 times per week for 30 minutes or longer) Smoking Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids) Renal insufficiency (serum creatinine > 1.5mg/dl) Chronic active liver disease (Bilirubin > 17mmol/L, AST > 144 IU/L, or ALT>165IU/L) Pregnancy or breastfeeding.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael D Jensen, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

559055

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Reich Pamela

Phone

507-255-6062

reich.pamela@mayo.edu

First Name & Middle Initial & Last Name & Degree

Michael D Jensen, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

Learn more about this trial

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

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