Clinical trial NCT02880813: The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals
Official title: The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Change in body weight
timeFrame: 12 days
Secondary outcomes:
measure: Change in body composition
timeFrame: 12 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy Rothberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: