Skip to main content
OpenTrials
Completed

NCT Number: NCT03115424

Effect of GLP-1 Receptor Agonism After Sleeve Gastrectomy

Observational studies suggest that bariatric surgery is the most effective intervention for weight loss. Comparative effectiveness of Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) demonstrate that RYGB is significantly superior to SG in terms of weight loss and glycemic control. Both RYGB and SG increase GLP-1 concentrations which directly affect B-cell function. Data has shown that the postprandial rise in GLP-1 might affect feeding behavior after RYGB and to a lesser extent SG, where the increase in GLP-1 is less marked. In this study the investigators propose to randomize subjects undergoing SG to receive either placebo or Liraglutide, a GLP-1 receptor agonist, to compare weight loss and CV risk factors.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

A total of 75, non diabetic adults, scheduled for bariatric surgery at Mayo Clinic Rochester, will be enrolled. Of these, 25 will be scheduled for Roux-en-Y Gastric Bypass surgery (RYGB), while the remainder (50) will be scheduled for Sleeve Gastrectomy (SG). The study team will play no role in assignment of the surgical procedure. Following surgery, at month 3, subjects undergoing SG will be randomized to either Saxenda or placebo, subcutaneously once daily. Subjects randomized to Saxenda or placebo will take for the duration of the study (33 months). Follow up study visits for all subjects will be timed to coincide with the standard clinical follow up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-65 years of age
  • Seen at Mayo Clinic Nutrition Clinic and have received authorization for bariatric surgery.
  • No active physical illness which will interfere with mobility or weight loss after bariatric surgery.
  • Females who are sexually active and able to become pregnant must agree to use birth control for duration of study if randomized to Saxenda/Placebo.

Exclusion criteria

  • Prior use of glucose lowering medication in the 3 months prior to screening.
  • A fasting glucose ≥ 126mg/dl or an HbA1c ≥ 6.5% will be taken as evidence of type 2 diabetes and therefore patients will be deemed ineligible for participation.
  • Prior abdominal surgery other than cholecystectomy, appendectomy or hysterectomy.
  • Pregnancy or active consideration of pregnancy during the period of study. Subjects will be discontinued if they become pregnant during the study.
  • Hypersensitivity to liraglutide or any product components.
  • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2.
  • Prior history of pancreatitis, cholelithiasis or cholecystitis.
  • Concurrent use of insulin or any other GLP-1 receptor agonist.
  • Active, severe psychiatric disease

Treatment and study plan

Saxenda

Drug

Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects will be recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will be randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Other names: Liraglutide

Placebos

Drug

Subjects will be recruited and screened prior to undergoing bariatric surgery.Subjects undergoing SG will be randomized 1:1 at months 3 post surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Other names: Placebo for Saxenda (Liraglutide)

RYGB

Procedure

Subjects will be recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.

Primary outcomes

  1. Weight

    Time frame: baseline and 36 months

    Subjects calculated weight in kilograms

Secondary outcomes

  1. Systolic Blood Pressure

    Time frame: baseline and 36 months

    Systolic blood pressure (top number of blood pressure reading)

  2. Diastolic Blood Pressure

    Time frame: baseline and 36 months

    Diastolic blood pressure (bottom number of blood pressure reading)

  3. Low-density Lipoprotein (LDL)

    Time frame: baseline and 36 months

    LDL's carry cholesterol through the bloodstream. LDL is called bad cholesterol because high amounts can form plaques in the blood vessels, increasing risk for heart disease. Adult normal range is less than 100 mg/dL.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study title

Effect of GLP-1 Receptor Agonism on Weight and Caloric Intake in Subjects After Sleeve Gastrectomy

Important dates

Study start
2017
Primary completion
2023
Study completion
2024
First posted
Apr 14, 2017
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.