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

The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Binge Eating Behaviour
• Intervention / Treatment: Drug: Liraglutide; Behavioral: Diet and Exercise

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
      • University Kebangsaan Malaysia Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; liraglutide; Other Names: Victoza; Behavioral: Diet and Exercise; diet and exercise
Active Comparator: Lifestyle counselling; Diet and Exercise	Behavioral: Diet and Exercise; diet and exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in binge eating scale score	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Reduction in weight	12 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Profile of hormones	12 weeks

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: November 28, 2012
• First Posted (Estimate): November 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 1, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Body Weight; Hyperphagia; Bulimia; Binge-Eating Disorder; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: FF0192012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No