The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals

Completed · Not applicable

Conditions studied: Obesity

In brief

This pilot study will look at whether infusion of nutrients into the duodenum or into the stomach will result in: 1. decrease in hunger and food intake 2. greater weight loss due to loss of body fat with reductions in waist and hip circumferences 3. improvements in other weight-related health conditions such as diabetes, high blood pressure, and high blood triglycerides. Inclusion criteria: 25-60 years old with a BMI of ≥ 30≤55 kg/m2. Subjects (16 individuals) will be in the study for 12 days and have a dobhoff tube placed at the start of the study. Subjects will visit MCRU daily for 12 days where meals will be provided, and where anthropometric measures, blood work during an oral mixed meal tolerance test (study start and study end), and surveys will be completed. The dobhoff tube will remain in place until the end of the study.

Key facts

Study ID

NCT02880813

Run by

University of Michigan

People needed

8

Starts

2016-08-01

Expected to finish

2018-12-01

Last updated by the study team

2018-12-20

Who can join

Age: 25 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects between the ages of 25 and 60 years
• with body mass index (BMI) ≥30≤55 kg/m2

You may not qualify if…

• significant heart, kidney, liver, gastrointestinal tract (including gastrointestinal reflux disease), autoimmune disorders such as lupus erythematosus, neurological, psychiatric or endocrine disorders (Type 1 diabetes, adrenal, pituitary or uncontrolled thyroid disease), any previous surgeries on gastrointestinal tract, HIV/AIDS, anemia, clotting disorders, cancers other than minor skin cancers.
• individuals taking anti-obesity drugs, or appetite suppressants within the last 2 months.
• Individuals who have already undergone weight loss surgery are excluded.
• Women who intend to get pregnant, pregnant women and women who are nursing
• people who have a history of eating disorder such as bulimia or binge eating, or a history of or current substance abuse (alcohol, marijuana, cocaine, tobacco etc.).
• people who have stopped smoking within the previous 6 months and
• people with weight changes greater than 5 kg (about 11 pounds) within the previous 3 months.
• individuals who plan to move within 1 year.

Where it is running

• Michigan Medicine — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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