NCT01484873

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Jun 2012

Typical duration for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 2, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 11, 2016

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

October 20, 2011

Results QC Date

February 9, 2016

Last Update Submit

January 17, 2017

Conditions

ObesityOverweightCraniopharyngioma

Keywords

ExenatideByettaHypothalamic ObesityObesityCraniopharyngioma

Outcome Measures

Primary Outcomes (1)

  • Body Weight (kg)

    Change in body weight from baseline to end of study

    baseline, 50 weeks

Secondary Outcomes (4)

  • Resting Energy Expenditure (Kcals Per Day)

    baseline, 50 weeks

  • Visual Analogue Scales for Post-meal Satiety

    baseline, 50 weeks

  • Insulin Secretion (Area Under the Curve)

    baseline, 50 weeks

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

    baseline, 50 weeks

Study Arms (1)

Exenatide

EXPERIMENTAL

All patients received exenatide 10mcg BID x 50 weeks

Drug: Exenatide

Interventions

ExenatideDRUG

Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.

Also known as: Byetta
Exenatide

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

  • 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.

    PMID: 27133664RESULT

MeSH Terms

Conditions

ObesityOverweightCraniopharyngiomaSexual Infantilism

Interventions

Exenatide

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueGonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGonadal DisordersEndocrine System DiseasesHypogonadism

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Results Point of Contact

Title
Ashley Shoemaker
Organization
Vanderbilt University
ashley.h.shoemaker@vanderbilt.edu
615-343-8116

Study Officials

  • Ashley Shoemaker, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

October 20, 2011

First Posted

December 2, 2011

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 3, 2017

Results First Posted

August 11, 2016

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)