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

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ClinicalTrials.gov Identifier: NCT01739049
Recruitment Status : Completed
First Posted : November 30, 2012
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

Tracking Information
First Submitted Date  ICMJE November 28, 2012
First Posted Date  ICMJE November 30, 2012
Last Update Posted Date May 4, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Reduction in binge eating scale score [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01739049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2012)
Reduction in weight [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 28, 2012)
Profile of hormones [ Time Frame: 12 weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Influence of Appetite Related Hormones in Binge Eating Behaviour Among the Overweight and Obese
Official Title  ICMJE The Influence of Appetite-Related Central and Gut Hormones in Modulating Binge Eating Behaviour in Obese and Overweight Healthy Subjects
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Binge Eating Behaviour
Intervention  ICMJE
  • Drug: Liraglutide
    liraglutide
    Other Name: Victoza
  • Behavioral: Diet and Exercise
    diet and exercise
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Liraglutide
    • Behavioral: Diet and Exercise
  • Active Comparator: Lifestyle counselling
    Diet and Exercise
    Intervention: Behavioral: Diet and Exercise
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 1, 2017)
42
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2012)
60
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01739049
Other Study ID Numbers  ICMJE FF0192012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Universiti Kebangsaan Malaysia Medical Centre
Study Sponsor  ICMJE Universiti Kebangsaan Malaysia Medical Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Universiti Kebangsaan Malaysia Medical Centre
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP