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

NCT ID: NCT03868592

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Gastric sleeve surgery

before and after weight loss from bariatric surgery

Group Type EXPERIMENTAL

Gastric sleeve/bariatric surgery

Intervention Type PROCEDURE

weight loss

Interventions

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Gastric sleeve/bariatric surgery

weight loss

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Michael D. Jensen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael D Jensen, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Reich Pamela

Role: primary

507-255-6062

Other Identifiers

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17-005349

Identifier Type: -

Identifier Source: org_study_id

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