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Trial record 6 of 6 for:    "Hypothalamic Obesity" | "Hormones"

Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor

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ClinicalTrials.gov Identifier: NCT01484873
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : August 11, 2016
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Ashley Shoemaker, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE October 20, 2011
First Posted Date  ICMJE December 2, 2011
Results First Submitted Date  ICMJE February 9, 2016
Results First Posted Date  ICMJE August 11, 2016
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
Body Weight (kg) [ Time Frame: baseline, 50 weeks ]
Change in body weight from baseline to end of study
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
Body Weight (kg) [ Time Frame: baseline and 52 weeks ]
Change in body weight from baseline to end of study
Change History Complete list of historical versions of study NCT01484873 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • Resting Energy Expenditure (Kcals Per Day) [ Time Frame: baseline, 50 weeks ]
    Change in resting energy expenditure from baseline to 50 weeks
  • Visual Analogue Scales for Post-meal Satiety [ Time Frame: baseline, 50 weeks ]
    Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).
  • Insulin Secretion (Area Under the Curve) [ Time Frame: baseline, 50 weeks ]
    Change in insulin secretion from baseline
  • Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life) [ Time Frame: baseline, 50 weeks ]
    Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
  • Resting Energy Expenditure (Kcals Per Day) [ Time Frame: baseline and 50 weeks ]
    Change in resting energy expenditure from baseline to 50 weeks
  • Free-living energy expenditure (kcals per day) [ Time Frame: baseline and 50 weeks ]
    Change in free-living energy expenditure from baseline to 50 weeks
  • Visual analogue scales for satiety [ Time Frame: baseline and 50 weeks ]
    Change in visual analogue scales scores from baseline to 50 weeks
  • Insulin Secretion (Area Under the Curve) [ Time Frame: baseline and 50 weeks ]
    Insulin secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.
  • Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life) [ Time Frame: baseline and 50 weeks ]
    Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks
  • Glucagon secretion (area under the curve) [ Time Frame: baseline and 50 weeks ]
    Glucagon secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.
  • GLP-1 secretion (area under the curve) [ Time Frame: baseline and 50 weeks ]
    GLP-1 secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.
  • Ghrelin secretion (area under the curve) [ Time Frame: baseline and 50 weeks ]
    Ghrelin secretion will be measured at 0, 30, 60, 90 and 120 minutes during an oral glucose tolerance test and AUC will be determined at baseline and 50 weeks.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight Loss Study for Patients With Obesity Due to Craniopharyngioma or Other Brain Tumor
Official Title  ICMJE Effects of Exenatide on Body Weight in Patients With Hypothalamic Obesity
Brief Summary The purpose of this study is to determine whether exenatide can cause weight loss in patients with a history of craniopharyngioma or other brain lesion.
Detailed Description

Hypothalamic obesity occurs in up to 60% of patients with tumors in the hypothalamic region, most commonly craniopharyngiomas. Hypothalamic dysfunction can be due to tumor infiltration and as a consequence of surgery or radiation therapy. Survivors who develop obesity have greater morbidity and mortality than normal weight survivors. Prevention and treatment of obesity in this population is vital in order to decrease the morbidity and mortality from diabetes, stroke and myocardial infarction.

Exenatide (Byetta®) is a GLP-1 homologue that was FDA approved for treatment of type 2 diabetes in 2005. It also decreases the rate of gastric emptying and increases satiety and has been shown to cause weight loss in some people. Exenatide may improve insulin sensitivity and satiety in patients with hypothalamic obesity but without the risks of bariatric surgery. The investigators hypothesize that treatment with exenatide will lead to weight loss in patients with hypothalamic obesity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Overweight
  • Craniopharyngioma
Intervention  ICMJE Drug: Exenatide
Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
Other Name: Byetta
Study Arms  ICMJE Experimental: Exenatide
All patients received exenatide 10mcg BID x 50 weeks
Intervention: Drug: Exenatide
Publications * Lomenick JP, Buchowski MS, Shoemaker AH. A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity. Obesity (Silver Spring). 2016 Jun;24(6):1222-5. doi: 10.1002/oby.21493. Epub 2016 May 2.

*   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: December 1, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 40 years old
  • History of craniopharyngioma or other lesion in the hypothalamic region
  • Greater than 6 months post-treatment, including chemotherapy, surgery or radiation
  • BMI >30 mg/m2
  • Females must be post-menopausal, surgically sterile or using effective birth control for at least 12 weeks

Exclusion Criteria:

  • HgbA1C >7%
  • Use of diabetes medications other than metformin in the past 12 weeks, including exenatide
  • Use of weight loss drugs or initiation of a weight loss program in past 3 months
  • Impaired renal function or history of kidney transplant
  • History of gall stones (unless s/p cholecystectomy), pancreatitis or alcoholism
  • Personal or family history of medullary carcinoma of the thyroid or MEN type 2
  • History of gastroparesis or other gastric motility problems as exenatide decreases gastric motility
  • History of allergic reaction to exenatide or other medication components
  • Other significant comorbidities other than pituitary deficiencies
  • Currently prescribed warfarin (exenatide may alter warfarin metabolism)
  • Pregnant or lactating females
  • History of severe hypoglycemia (BG <60 and requiring assistance from another person)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484873
Other Study ID Numbers  ICMJE 111185
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ashley Shoemaker, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashley Shoemaker, M.D. Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date January 2017

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