The Effects of Gastric or Duodenal Nutrient Infusion on Food Intake, Obesity and Comorbidities in Obese Individuals
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 25 - 60 |
| Updated: | 12/22/2018 |
| Start Date: | August 2016 |
| End Date: | December 2018 |
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.
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.
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.
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.
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.
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