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

NCT02880813 | Completed DMC

• 1 other identifier: HUM00106668
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will look at whether infusion of nutrients into the duodenum or into the stomach will result in:

1. 1.decrease in hunger and food intake
2. 2.greater weight loss due to loss of body fat with reductions in waist and hip circumferences
3. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  12 days

Secondary Outcomes (1)

• Change in body composition

  12 days

Study Arms (2)

Gastric

EXPERIMENTAL

gastric infusion

Other: Infusion

Duodenal

EXPERIMENTAL

Duodenal infusion

Other: Infusion

Interventions

Infusion OTHER

infusion of nutrients

Duodenal; Gastric

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Amy Rothberg, MD, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)