Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868592
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Michael D. Jensen, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: Gastric sleeve/bariatric surgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Study insulin action and adipose function before and after weight loss from gastric sleeve surgery
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 1, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: Gastric sleeve surgery
before and after weight loss from bariatric surgery
Procedure: Gastric sleeve/bariatric surgery
weight loss




Primary Outcome Measures :
  1. Long-term, substantial weight loss and insulin regulation of lipolysis [ Time Frame: 1 year ]
    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

  2. Long-term, substantial weight loss and insulin regulation of lipolysis [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868592


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 559055
Contact: wolhart Sarah, RNSC    507-255-6940    wolhart.sarah@mayo.edu   
Principal Investigator: Michael D Jensen, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Michael D Jensen, MD Mayo Clinic

Additional Information:
Layout table for additonal information
Responsible Party: Michael D. Jensen, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03868592     History of Changes
Other Study ID Numbers: 17-005349
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity, Morbid
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs