The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity

This study has been completed.
Sponsor:
Collaborator:
Schweizerischer Nationalfonds
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00946816
First received: July 20, 2009
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

Diseases characterized by abnormal low and high body weight are common in the community and are associated with significant morbidity, mortality and health care related costs.

Genetic, dietary, social and psychologic factors all play an important part in these conditions; however the central role of gastrointestinal (GI) function and the control of nutrient delivery to the small bowel has not been well described in health or disease.

We propose that the GI response to feeding varies inversely with body weight. This hypothesis predicts that as body weight increases, the response to a given meal decreases in terms of motility, neurohormonal feedback, sensation and satiety. This provides an attractive explanation for why thin individuals stop eating after a small amount of food (i.e. limited gastric relaxation, rapid gastric emptying, powerful nutrient feedback with early satiety)and, conversely, why obese patients continue to eat even after nutritional requirements have been met (i.e. large gastric relaxation, slow gastric emptying, weak nutrient feedback with delayed satiety).

This project will apply MRI and Breath Tests to assess GI motility, hormonal feedback, visceral sensation and satiety in patients with pathologically low (anorexia nervosa) and high (morbid obesity) body weight and in healthy, normal weight controls.

Participants will include: Group A: normal weight, healthy volunteers (n=24: BMI: 18.5-24.9 kg/m2) Group B: patients with anorexia nervosa (DSMIV criteria and BMI: <16 kg/m2) B1: anorexia restricting type (n=12-20 over 2 years) and B2: anorexia bulimia type (n=20 over 2 years) Group C: patients with morbid obesity (BMI: 30-40 kg/m2) C1: obese (n=20 over 2 years) and C2: obese with DM type II (n=20 over 2 years).

Two studies will be performed

  1. Cross-sectional study: The effects of a test meal on GI motility, hormonal feedback, visceral sensation and satiety in healthy controls and in patients with anorexia and obesity
  2. Longitudinal study: The effects of dietary treatment (i.e. weight change) on GI motility, hormonal feedback, visceral sensation and satiety in patients with anorexia and obesity

Condition Intervention
Anorexia Nervosa
Obesity
Healthy Participants
Behavioral: Nutritional Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Dietary Intervention on Gastrointestinal Motility, Hormonal Feedback, Visceral Sensation and Satiety in Patients With Anorexia Nervosa and Obesity

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: September 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Anorexia Nervosa Behavioral: Nutritional Intervention
Nutritional Intervention
Active Comparator: Obesity Behavioral: Nutritional Intervention
Nutritional Intervention
Active Comparator: Healthy volunteers Behavioral: Nutritional Intervention
Nutritional Intervention

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

In addition to satisfying specific DSMIV criteria for anorexia nervosa (B1, B2) or WHO criteria for obesity (C1), or obesity and diabetes mellitus type II (C2), general inclusion criteria include:

  • aged at least 18 and not more than 40 years
  • able to communicate well with the investigators and provide written consent
  • no physical co-morbidity requiring active treatment, in particular diabetes mellitus, impairment of liver or kidney function (subjects with diabetes mellitus type II are eligible for study group C2)
  • no psychiatric (DSM IV) disorders limiting the ability to comply with study requirements
  • no use of medications influencing upper GI motility within one week of the study (i.e. nitrates, prokinetic drugs, macrolide antibiotics). Acid suppression and antihypertensive medication beta-blocker, calcium channel blockers are acceptable.
  • no evidence of current drug or alcohol abuse
  • no history of gastrointestinal disease or surgery except appendicectomy or hernia repair
  • females will take a urine pregnancy test before each study, any participant with a positive pregnancy test will be excluded (females will be investigated always in the same menstrual phase)

Exclusion criteria:

• pregnancy

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00946816

Locations
Switzerland
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Schweizerischer Nationalfonds
Investigators
Principal Investigator: Michael Fried, Professor MD University Hospital Zurich, Gastroenterology and Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT00946816     History of Changes
Other Study ID Numbers: SNF 320030_1253331
Study First Received: July 20, 2009
Last Updated: November 13, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Obesity
Anorexia
Anorexia Nervosa
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Eating Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014