Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier:
NCT01739049
First received: November 28, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Binge Eating Behaviour
Drug: Liraglutide
Behavioral: Diet and Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Universiti Kebangsaan Malaysia Medical Centre:

Primary Outcome Measures:
  • Reduction in binge eating scale score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Profile of hormones [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide and lifestyle counselling

Liraglutide 0.6mg od for 1st week, then 1.2mg od for 2nd week then 1.8mg od until 12 weeks.

Diet and Exercise

Drug: Liraglutide
Other Name: Victoza
Behavioral: Diet and Exercise
Active Comparator: Lifestyle counselling
Diet and Exercise
Behavioral: Diet and Exercise

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739049

Locations
Malaysia
University Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
Principal Investigator: Nor Azmi Kamaruddin, Professor of Medicine UKMMC
Principal Investigator: Rohana Abdul Ghani, Ass Professor of Medicine UKMMC
Principal Investigator: Suehazlyn Zainuddin, MMed UKMMC
Principal Investigator: Wan Nazaimoon Wan Mohamud, Phd Biochemistry IMR
Principal Investigator: Sarah Anne Robert, Mpharm UKMMC
  More Information

No publications provided

Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT01739049     History of Changes
Other Study ID Numbers: FF0192012
Study First Received: November 28, 2012
Last Updated: November 28, 2012
Health Authority: Malaysia: Institutional Review Board

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Overweight
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 28, 2014