Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage

NCT01783717 | Unknown DMC

• 1 other identifier: 2012-217
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effect of exenatide on body weight and glycemic control in subjects with obesity and/or diabetes mellitus due to hypothalamic damage.

Conditions

Hypothalamic Obesity; Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

• Change in body weight frome baseline to end of the study.

  3 months

• BMI

  baseline and 3 months

• HbA1c

  baseline and 3 months

• Blood glucose level.

  3 months.

• Beta cell function.

  baseline and 3 months

• Insulin sensitivity.

  baseline and 3 months

Secondary Outcomes (7)

• Waistline

  baseline and 3 months

• Ratio of body fat

  baseline and 3 months

• The amount of daily energy intake

  baseline and 3 months

• Resting energy expenditure (kcals per day)

  baseline and 3 months

• Grade of metabolic equivalents (MET) scales

  baseline and 3 months

Study Arms (1)

Exenatide

EXPERIMENTAL

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks

Drug: Exenatide

Interventions

Exenatide DRUG

5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks

Also known as: Byetta

Exenatide

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18 and 55 years old;
• Greater than 6 months post-treatment (including surgery, radiotherapy or chemotherapy) of craniopharyngioma or other diseases in the hypothalamic region;
• BMI≧28kg/m2 and/or diabetes mellitus;
• Greater than 3 months after adequate replacement therapy for hypothalamic-pituitary-adrenal (HPA) axis and hypothalamic-pituitary-thyroid (HPT) axis;
• Sign informed consent document.

You may not qualify if:

• Less than 6 months post surgery or radiotherapy or chemotherapy for craniopharyngioma or other diseases in the hypothalamic region;
• Inadequate replacement for the HPA axis and HPT axis or undertaking adjustments of the kind or dose of the substitutive medicine;
• Use of weight loss drugs or initiation of a weight loss program within past 3 months;
• Use of GLP-1 agonists or analogues or dipeptidyl peptidase IV (DPP-IV) inhibitors within past 3 months;
• History of bariatric surgery;
• Diagnosed with simple obesity or diabetes mellitus prior to the hypothalamic disorders, and those diagnosed with type 1 diabetes mellitus;
• With end-stage-renal diseases or history of kidney transplant or complicated with acute/chronic kidney failure (GFR≦30ml/min);
• History of inflammatory bowel diseases or gastroparesis or other gastric mortility problems;
• History of pancreatitis or chronic cholecystitis;
• History of allergic reaction to exenatide or other medication components;
• Undertaking warfarin;
• Pregnant or lactating women;
• Are participating in, or have participated in other drug clinical trials within past 3 months.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Department of Endocrinology and Metabolism

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Sexual Infantilism; Diabetes Mellitus

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Li yi ming

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang z yun

CONTACT

86-21-52888286

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 25, 2012
• First Posted: February 5, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

CN (1)