The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    

Intervention name(s): Infusion
Intervention type(s): Other
Intervention description(s): infusion of nutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science