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Completed

NCT Number: NCT02779075

Exendin-9,39 and Satiety After Bariatric Surgery

The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
  • Healthy, with no active systemic illness

Exclusion criteria

  • Pregnancy
  • Functional or organic bowel symptoms
  • Systemic illness
  • Diabetes
  • Bariatric surgery > 2 years

Treatment and study plan

Saline

Drug

Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.

Exendin-9,39

Drug

Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.

Primary outcomes

  1. Caloric Intake

    Time frame: 5 hours

    caloric intake from a free choice buffet within 5 hours after ingestion of a standard meal

Secondary outcomes

  1. Gastrointestinal Transit Measured Using Scintigraphy

    Time frame: 4 hours

    Time taken to empty 50% of stomach contents (GE50) measured using scintigraphy over the 4 hours after ingestion of a labeled meal

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • The Obesity Society

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 20, 2016
Registry last updated
May 1, 2020

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.

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