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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03868592
• Other study ID #: 17-005349
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: May 2025

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity, Morbid
• Weight Loss

Intervention

Procedure:
• Gastric sleeve/bariatric surgery
weight loss

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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 changes in adipocyte perilipin 1 dephosphorylation in response to insulin.	1 year
Other	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 changes in adipocyte HSL dephosphorylation in response to insulin.	1 year
Primary	adipose macrophage content, adipose IL-6 and TNF gene expression	Adipose tissue macrophage content as assessed by immunohistochemistry using stains for CD36, CD14 and CD206 will be done. mRNA expression for IL-6 and TNF will be measured	Before bariatric surgery and approximately 1 year after surgery
Primary	insulin regulation of lipolysis (IC50)	The ability of insulin to suppress FFA palmitate release will be assessed using a 2-step insulin clamp and isotope dilution techniques for palmitate kinetics	Before bariatric surgery and approximately 1 year after surgery
Secondary	adipocyte perilipin 1 and HSL and ATGL	These proteins will be measured using capillary Western methods.	Before bariatric surgery and approximately 1 year after surgery