Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese
Primary Purpose
Binge Eating Behaviour
Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
Liraglutide
Diet and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Binge Eating Behaviour
Eligibility Criteria
Inclusion Criteria:
- Subjects who are willing to participate and sign informed consent form
- Subjects who are able to answer the questionnaire
- Subjects who are between 18-65 years old
- Subjects with BMI 30-45
- Subjects who are willing to administer injection
Exclusion Criteria:
- Pregnant subjects
- Subjects with chronic medical illness such as end stage renal failure, hepatic failure, diabetes mellitus, thyroidism, etc
- Subjects on medication that may influence appetite, satiety and weight
- Subjects that plan to move out of state/country
Sites / Locations
- University Kebangsaan Malaysia Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liraglutide and lifestyle counselling
Lifestyle counselling
Arm Description
Liraglutide 0.6mg od for 1st week, then 1.2mg od for 2nd week then 1.8mg od until 12 weeks. Diet and Exercise
Diet and Exercise
Outcomes
Primary Outcome Measures
Reduction in binge eating scale score
Secondary Outcome Measures
Reduction in weight
Full Information
NCT ID
NCT01739049
First Posted
November 28, 2012
Last Updated
May 1, 2017
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
1. Study Identification
Unique Protocol Identification Number
NCT01739049
Brief Title
Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese
Official Title
The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Malaysia has increasing challenges in lifestyle related diseases, which is related to eating habits and disorders. According to the National Health & Morbidity Survey in 2011; it was reported the prevalence of obesity is 15.1% in 2011; or 2.5 million of the population,; an increase of 7/9% when compared to the 14% prevalence in 2006. Binge eating is a symptom described in various eating disorders. It is an under-diagnosed medical condition closely linked to higher body mass index (BMI) or obesity as well as personality psychopathology, psychiatric and psychological disturbances. Meta-analysis has demonstrated that extremely strict restriction in dietary calorie and fat intake is needed to achieve meaningful weight loss. Appetite and satiety are influenced by extremely complex central and gut-related hormonal systems which modulate the regulation of food intake Centrally acting hormones include Neuropeptide Y (NPY), agouti gene-related peptide, orexin which are appetite-stimulating, melanocortins and alpha-melanocortin-stimulating hormone which promote satiety.
Gut-related peptides include ghrelin secreted by the stomach and the duodenum has orexigenic (appetite stimulating) effect; leptin secreted by adipose tissue has anorexic (appetite inhibiting) effect, cholecystokinin, glucagon-like peptide-1 (GLP-1) secreted by the proximal gastrointestinal tract which has slight anorexic effect, and peptide YY (PYY).
Appetite and obesity have also been commonly related to stress and may influence binge-eating episodes. Previous studies have demonstrated that high stress hormone cortisol is associated with increased appetite and cravings, with preference for high carbohydrate content, thus leading to weight gain.
In the previous study performed by our group on 738 normal subjects who were staffs of the Ministry of Health, Putrajaya, we found a prevalence of 19% binge eating behaviour, 83% of whom were either obese or overweight.
GLP-1 analogue used for the treatment of type 2 diabetes and is also shown to produce and maintain weight loss. Liraglutide, which provides a supra physiological amount of GLP-1 may cause appetite inhibition thus may benefit in reducing binge eating. The aim of this study is to closely observe the extensive profile of neuropeptide Y, ghrelin, leptin and GLP-1, influenced by a standard meal in binge eaters in comparison to non-binge eating controls. In addition, we aim to determine the association between binging and the respective appetite-related hormones and also cortisol. Finally we will also be assessing the efficacy of novel hormonal treatment of Liraglutide in reducing binge eating.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Behaviour
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide and lifestyle counselling
Arm Type
Experimental
Arm Description
Liraglutide 0.6mg od for 1st week, then 1.2mg od for 2nd week then 1.8mg od until 12 weeks.
Diet and Exercise
Arm Title
Lifestyle counselling
Arm Type
Active Comparator
Arm Description
Diet and Exercise
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Other Intervention Name(s)
Victoza
Intervention Description
liraglutide
Intervention Type
Behavioral
Intervention Name(s)
Diet and Exercise
Intervention Description
diet and exercise
Primary Outcome Measure Information:
Title
Reduction in binge eating scale score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Reduction in weight
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Profile of hormones
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who are willing to participate and sign informed consent form
Subjects who are able to answer the questionnaire
Subjects who are between 18-65 years old
Subjects with BMI 30-45
Subjects who are willing to administer injection
Exclusion Criteria:
Pregnant subjects
Subjects with chronic medical illness such as end stage renal failure, hepatic failure, diabetes mellitus, thyroidism, etc
Subjects on medication that may influence appetite, satiety and weight
Subjects that plan to move out of state/country
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nor Azmi Kamaruddin, Professor of Medicine
Organizational Affiliation
UKMMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rohana Abdul Ghani, Ass Professor of Medicine
Organizational Affiliation
UKMMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suehazlyn Zainuddin, MMed
Organizational Affiliation
UKMMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wan Nazaimoon Wan Mohamud, Phd Biochemistry
Organizational Affiliation
IMR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Anne Robert, Mpharm
Organizational Affiliation
UKMMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Kebangsaan Malaysia Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
56000
Country
Malaysia
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25870084
Citation
Robert SA, Rohana AG, Shah SA, Chinna K, Wan Mohamud WN, Kamaruddin NA. Improvement in binge eating in non-diabetic obese individuals after 3 months of treatment with liraglutide - A pilot study. Obes Res Clin Pract. 2015 May-Jun;9(3):301-4. doi: 10.1016/j.orcp.2015.03.005. Epub 2015 Apr 11.
Results Reference
derived
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Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese
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