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

NCT01739049 | Completed Phase 4

• 1 other identifier: FF0192012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating Behaviour

Outcome Measures

Primary Outcomes (1)

• Reduction in binge eating scale score

  12 weeks

Secondary Outcomes (1)

• Reduction in weight

  12 weeks

Other Outcomes (1)

• Profile of hormones

  12 weeks

Study Arms (2)

Liraglutide and lifestyle counselling

EXPERIMENTAL

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; Behavioral: Diet and Exercise

Lifestyle counselling

ACTIVE COMPARATOR

Diet and Exercise

Behavioral: Diet and Exercise

Interventions

Liraglutide DRUG

liraglutide

Also known as: Victoza

Liraglutide and lifestyle counselling

Diet and Exercise BEHAVIORAL

diet and exercise

Lifestyle counselling; Liraglutide and lifestyle counselling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

University Kebangsaan Malaysia Medical Centre

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 25870084 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Liraglutide; Diet; Exercise

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  Institute for Medical Research, Inc.

  PRINCIPAL INVESTIGATOR

• Sarah Anne Robert, Mpharm

  UKMMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: November 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2015
• Last Updated: May 4, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)