The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
Primary Purpose
Anorexia Nervosa, Obesity, Healthy Participants
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Nutritional Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia Nervosa
Eligibility 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
Sites / Locations
- University Hospital Zurich, Gastroenterology and Hepatology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Anorexia Nervosa
Obesity
Healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety
Secondary Outcome Measures
Full Information
NCT ID
NCT00946816
First Posted
July 20, 2009
Last Updated
November 13, 2012
Sponsor
University of Zurich
Collaborators
Schweizerischer Nationalfonds
1. Study Identification
Unique Protocol Identification Number
NCT00946816
Brief Title
The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
Official Title
The Effects of Dietary Intervention on Gastrointestinal Motility, Hormonal Feedback, Visceral Sensation and Satiety in Patients With Anorexia Nervosa and Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Schweizerischer Nationalfonds
4. Oversight
5. Study Description
Brief Summary
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
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Obesity, Healthy Participants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anorexia Nervosa
Arm Type
Active Comparator
Arm Title
Obesity
Arm Type
Active Comparator
Arm Title
Healthy volunteers
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Nutritional Intervention
Intervention Description
Nutritional Intervention
Primary Outcome Measure Information:
Title
The GI response to a given meal in terms of: motility, neurohormonal feedback, sensation and satiety
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fried, Professor MD
Organizational Affiliation
University Hospital Zurich, Gastroenterology and Hepatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Gastroenterology and Hepatology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28056812
Citation
Bluemel S, Menne D, Milos G, Goetze O, Fried M, Schwizer W, Fox M, Steingoetter A. Relationship of body weight with gastrointestinal motor and sensory function: studies in anorexia nervosa and obesity. BMC Gastroenterol. 2017 Jan 5;17(1):4. doi: 10.1186/s12876-016-0560-y.
Results Reference
derived
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The Effects of Dietary Intervention on Gastrointestinal Function in Patients With Anorexia Nervosa and Obesity
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