Effects of Exenatide on Hypothalamic Obesity

NCT01061775 | Completed Phase 1 Results DMC

• 1 other identifier: 0903-028
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim of this study is to evaluate the effect of Exenatide on weight status (change in body mass index) of children treated for craniopharyngioma that have developed hypothalamic obesity at Children's Hospitals and Clinics of Minnesota. We hypothesize that Exenatide given to hypothalamic obese children for 6 months will reduce their body mass index significantly from baseline.

Conditions

Hypothalamic Obesity

Keywords

Hypothalamic Obesity; Exenatide; Byetta; Craniopharyngioma

Outcome Measures

Primary Outcomes (2)

• BMI Change

  BMI was collected at baseline and 24 weeks

  24 weeks

• Waist to Height Ratio (WHtR)

  Waist circumference was measured at the natural waist level (midway between the lowest rib margin and the iliac crest) at baseline and 24 weeks

  24 weeks

Secondary Outcomes (2)

• Childhood Eating Behavior Questionnaire (CEBQ)

  24 weeks

• Calorie Intake Based on 3-day Diet Records

  24 weeks

Study Arms (1)

Exenatide

EXPERIMENTAL

5mcg of exenatide will be given twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.

Drug: Exenatide

Interventions

Exenatide DRUG

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.

Also known as: Byetta

Exenatide

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \>/=6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
• years old
• Age-and sex-adjusted BMI \>/=95%
• Parent sign consent and patient sign assent

You may not qualify if:

• \< 6 months post surgical or radiation or chemotherapy treatment for 1° craniopharyngiomas or other suprasellar tumors
• Pregnant or breastfeeding, or those women who plan to get pregnant
• Renal impairment
• Gastroparesis
• Pancreatitis
• Diabetes
• \<1 month post initiation of Metformin treatment
• Prescription or over-the-counter weight loss medications within 3 months of screening
• Are actively participating in, or have participated in a formal weight loss program within the last 3 months
• Have had bariatric surgery

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead
• Amylin Pharmaceuticals, LLC.: collaborator

Study Sites (2)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's Hospitals & Clincis of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Related Links

• Hospital website

MeSH Terms

Conditions

Sexual Infantilism; Craniopharyngioma

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Jennifer Abuzzahab
• Organization: Children's Hospitals and Clinics of Minnesota

jennifer.abuzzahab@childrensmn.org

651-220-6867

Study Officials

• M. Jennifer Abuzzahab, MD

  Children's Hospitals & Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2010
• First Posted: February 3, 2010
• Study Start: January 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: March 15, 2019
• Last Updated: October 8, 2019
• Results First Posted: March 21, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)