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

NCT ID: NCT02880813

Last Updated: 2018-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-12-31

Brief Summary

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.

Detailed Description

The investigators propose a pilot study to evaluate whether mimicking rapid gastric emptying with duodenal infusion (DI) of nutrients (treatment) compared to gastric infusion (GI) of nutrients (control) over 12 days will result in 1) decrease in caloric intake 2) loss of body weight 3) improvements in comorbidities, particularly glucose metabolism, decrease in blood triglycerides and hypertension and increase in serum bile acids. Individuals eligible for the study will provide written informed consent. A comprehensive health and weight history will be obtained and physical exam obtained. Randomization will be 1:1 to DI vs. GI. There will be 8 individuals per treatment arm. A Dobhoff tube will be placed in each participant from nose either into duodenum (DI) or into stomach (GI). Participants will be allowed to eat three buffet style meals per day at 8.30 am, noon and 4 pm. The food intake will be noted for each meal by the investigators. Participants will note their feelings of hunger, fullness, bloating, nausea, and energy on a visual analogue scale every fifteen minutes for an hour starting at the initiation of the infusion. The placement of the tube (into stomach or duodenum) will be confirmed on day 1, day 6 and day 12 with radiographs. If necessary, fluoroscopy will be used only once during the study on day 1 to adjust the placement of the tube. During the study, the health of the participants will also be monitored and medications (if any) will be adjusted (if required) on a daily basis.

Intervention Group:

For first three days of the study (starting on Day#2), DI with 180 ml of warm saline will be given over 6 to 15 minutes through the Dobhoff tube starting a minute before initiation of each of the meal. For the remaining 7 days of the study, DI with nutrients in the form of 180 ml (266 Kcal) of warm Ensure Complete (Abbott Nutrition, OH) will be given over 6 to 15 minutes starting a minute before initiation of each meal. If they desire, participants will be allowed to eat a snack after the third meal.

Comparison group:

For first three days of the study (starting on Day#2), GI with 180 ml of warm saline will be given over 6 to 15 minutes through the Dobhoff tube starting a minute before initiation of each of the meal. For the remaining 7 days of the infusion part of the study, GI with nutrients in the form of 180 ml (266 Kcal) of warm Ensure Complete (Abbott Nutrition, OH) will be given over 6 to 15 minutes starting a minute before initiation of each meal. If they desire, participants will be allowed to eat a snack after the third meal.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Gastric

gastric infusion

Group Type: EXPERIMENTAL

Infusion

Intervention Type: OTHER

infusion of nutrients

Duodenal

Duodenal infusion

Group Type: EXPERIMENTAL

Infusion

Intervention Type: OTHER

infusion of nutrients

Interventions

Infusion

infusion of nutrients

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Amy E Rothberg

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amy Rothberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Michigan Medicine

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00106668

Identifier Type: -

Identifier Source: org_study_id