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Completed

NCT Number: NCT02929212

Effect of Number of Meals on Metabolism After Weight Loss Surgery

The purpose of this study is to determine the effect of meal size and texture on the levels of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake change after bariatric surgery and patients often eat multiple small low-calorie meals, a pattern that may affect blood glucose as well as incretin levels. Whether the release of GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in 'real life' setting of multiple small meals diet is unclear.

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Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital Center

New York, 10025, United States

About this study

The main goal is to study the effect of meal size and texture on incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small meals, with the order of the conditions randomly assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55% CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.

Recruitment and data gathering for this study were performed at St. Luke's Hospital in New York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

morbidly obese individuals, BMI above 35 and less than 50 kg/m2 who chose GBP as treatment for their obesity

  • Must be able to attend all study visits at St. Luke's Roosevelt Hospital Center in Manhattan, New York City
  • Individuals with or without Type 2 Diabetes Mellitus are eligible

Exclusion criteria

  • Patients with abnormal thyroid, renal function, known malabsorption syndrome or a seizure disorder requiring anti epileptic therapy, and/or elevation of liver enzymes three times above the normal limit.
  • Patients with intestinal conditions such as chronic diarrhea, diverticulitis, or irritable bowel syndrome.
  • Currently pregnant or nursing.
  • Known cardiovascular disease.
  • Patient with current mucosal (gastrointestinal, respiratory, urogenital) or skin (cellulitis) infection
  • Any other condition which, in the opinion of the investigators, may make the candidate unsuitable for participation in this study.
  • past history of severe food allergy
  • History of Type 1 Diabetes Mellitus
  • Individuals taking insulin, thiazolidinedione, exenatide, or DPP-IV inhibitors

Treatment and study plan

Solid meal

Other

Subjects will receive solid meals during meal study

liquid meal

Other

Subjects will receive liquid meals, during meal study

Acetaminophen

Drug

All subjects given acetaminophen to measure gastric emptying

Single, 600 kcal meal

Other

Subjects will receive a single, 600 kcal meal during meal study

Multiple, 200 kcal meals

Other

Subjects will receive three, 200 kcal meals, during meal study

Primary outcomes

  1. Difference in GLP-1 levels before and after gastric bypass surgery

    Time frame: 12-15 months

    Investigators will assess GLP-1 levels in subjects pre and post-GBP

  2. Difference in glucose levels before and after gastric bypass surgery

    Time frame: 12-15 months

    Investigators will assess glucose in subjects pre and post-GBP

  3. Difference in insulin levels before and after gastric bypass surgery

    Time frame: 12-15 months

    Investigators will assess insulin levels in subjects pre and post-GBP

Secondary outcomes

  1. Difference in GLP-1 levels in solid vs liquid meals

    Time frame: 12-15 months

    Investigators will assess GLP-1 levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

  2. Difference in glucose levels in solid vs liquid meals

    Time frame: 12-15 months

    Investigators will assess glucose levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

  3. Difference in insulin levels in solid vs liquid meals

    Time frame: 12-15 months

    Investigators will assess insulin levels in subjects eating either liquid or solid meals at both pre-surgery and post-surgery time points

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: LAF 28

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2016
Registry last updated
Feb 1, 2017

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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