Investigating Physiological Adaptations to Weight Loss

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by University of Melbourne.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

University of Melbourne

ClinicalTrials.gov Identifier:

NCT00870259

First received: March 26, 2009

Last updated: NA

Last verified: March 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	March 26, 2009
Last Updated Date	March 26, 2009
Start Date ^ICMJE	February 2008
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Difference in fasting and/or post-prandial hormone levels following weight loss and after weight maintenance compared with baseline [ Time Frame: 2, 6 and 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: March 26, 2009)	Difference in fasting and/or post-prandial hormone levels in ketotic compared with non-ketotic state [ Time Frame: week 8 vs week 10 ] [ Designated as safety issue: No ] Correlation of fasting and post-prandial hormone levels with ratings of hunger and satiety [ Time Frame: 0, 2, 6 and 12 months ] [ Designated as safety issue: No ] Association of psychosocial factors with successful weight maintenance [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Investigating Physiological Adaptations to Weight Loss
Official Title ^ICMJE	An Investigation of Physiological Adaptations Contributing to Weight Regain After Weight Loss
Brief Summary	The purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Obesity
Intervention ^ICMJE	Dietary Supplement: Optifast VLCD Meal replacement, three times daily for 8 weeks
Study Arm (s)	Not Provided
Publications *	Sumithran P, Prendergast LA, Delbridge E, Purcell K, Shulkes A, Kriketos A, Proietto J. Long-term persistence of hormonal adaptations to weight loss. N Engl J Med. 2011 Oct 27;365(17):1597-604.
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	80
Completion Date	Not Provided
Estimated Primary Completion Date	December 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: males and post-menopausal females aged over 18 years BMI 27-40kg/m2 weight-stable Exclusion Criteria: major comorbid medial condition (including diabetes) taking medications known to affect weight smoking
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT00870259
Other Study ID Numbers ^ICMJE	HP 508920
Has Data Monitoring Committee	No
Responsible Party	Professor Joseph Proietto, University of Melbourne
Study Sponsor ^ICMJE	University of Melbourne
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Melbourne
Verification Date	March 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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