Binge Eating Behaviour Clinical Trial
Official title:
The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects
| Verified date | May 2017 |
| Source | Universiti Kebangsaan Malaysia Medical Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 42 |
| Est. completion date | January 2015 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Malaysia | University Kebangsaan Malaysia Medical Centre | Kuala Lumpur | Wilayah Persekutuan |
| Lead Sponsor | Collaborator |
|---|---|
| Universiti Kebangsaan Malaysia Medical Centre |
Malaysia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Profile of hormones | 12 weeks | ||
| Primary | Reduction in binge eating scale score | 12 weeks | ||
| Secondary | Reduction in weight | 12 weeks |