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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Infusion

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastric; gastric infusion	Other: Infusion; infusion of nutrients
Experimental: Duodenal; Duodenal infusion	Other: Infusion; infusion of nutrients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	12 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in body composition	12 days

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Amy Rothberg, MD, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: HUM00106668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No