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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT01484873 (opens ClinicalTrials.gov in a new tab)Other id111185
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
10 participants (actual)
Sponsor
Vanderbilt University Medical Center · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jun 2012
Primary completion
Mar 2015
Completion
Mar 2015
First posted
2 Dec 2011 (estimated)
Last update posted
3 Mar 2017
Conditions
Obesity · Overweight · Craniopharyngioma

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph 2

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

    NCT01484873

    Jun 2012 to Mar 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ExenatideDrug

Arms1

  • Experimental

    Exenatide

    All patients received exenatide 10mcg BID x 50 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Body Weight (kg)

    Time frame · baseline, 50 weeks

    Registry description

    Change in body weight from baseline to end of study

Secondary outcomes(4)

  1. Resting Energy Expenditure (Kcals Per Day)

    Time frame · baseline, 50 weeks

    Registry description

    Change in resting energy expenditure from baseline to 50 weeks

  2. Visual Analogue Scales for Post-meal Satiety

    Time frame · baseline, 50 weeks

    Registry description

    Change in visual analogue scales scores from baseline to 50 weeks. Higher score indicates greater satiety (minimum 0, maximum 100).

  3. Insulin Secretion (Area Under the Curve)

    Time frame · baseline, 50 weeks

    Registry description

    Change in insulin secretion from baseline

  4. Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)

    Time frame · baseline, 50 weeks

    Registry description

    Change in the isotope excretion half life during a gastric emptying test at baseline and at 50 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline, 50 weeks

Body Weight (kg)

GroupValue (kg)
Exenatide-1.4
Secondary and other outcome results(4)
Secondary outcomeMean· baseline, 50 weeks

Resting Energy Expenditure (Kcals Per Day)

GroupValue (kcal/day)
Exenatide-157.7
Secondary outcomeMean· baseline, 50 weeks

Visual Analogue Scales for Post-meal Satiety

GroupValue (mm)
Exenatide-2.5
Secondary outcomeMean· baseline, 50 weeks

Insulin Secretion (Area Under the Curve)

GroupValue (120 min*uU/mL x)
Exenatide-89.3
Secondary outcomeMean· baseline, 50 weeks

Gastric Emptying Rate (13C-octanoic Acid Isotope Excretion Half Life)

GroupValue (minutes)
Exenatide12.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatideexenatide 10 mcg twice daily–0 / 1010 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2016

5 results

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.

Lomenick et al. 2016Obesity (Silver Spring, Md.)cited by 49

PMID 27133664PMC4882247DOI 10.1002/oby.21493PUB-27133664

Rights unknown5 results
Source linkSee results (5)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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