Hypothalamic ObesityNCT01783717
Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
A study testing Exenatide in people with Hypothalamic Obesity and Diabetes Mellitus, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypothalamic Obesity, Diabetes Mellitus
- What is being tested?
- Exenatide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Zhang z yun contact
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolism
Shanghai, Shanghai Municipality, 200040
Ye h ying, 86-21-52887027
Zhang z yun
About this study
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.
Read the detailed description
Patients with hypothalamus lesion caused by tumors in the hypothalamic region, such as craniopharyngioma and germ cell tumors, and inflammatory diseases are susceptible to develop severe obesity and diabetes mellitus. The occurrence of hypothalamic obesity in patients after surgery with or without radiotherapy for craniopharyngioma can be as high as 42-66%, and the incidence of type 2 diabetes mellitus of them is twice as much as healthy controls. Treatment of obesity and diabetes mellitus in this population is crucial for increasing morbidity and mortality. However, diet and exercise intervention has been proven useless in previous studies. Safe and effective medicine remains to be developed. Exenatide, a GLP-1 receptor agonist, which play an antihyperglycemic role through a variety of mechanisms, such as enhancing glucose-dependent insulin secretion, increasing beta cell mass and decreasing glucagon secretion, possesses a potent ability to induce satiety, slow gastric emptying and reduce food intake, resulting in weight loss both in diabetics and patients with simple obesity. Previous animal study has already shown GLP-1 agonist exendin-4 leads to reduction of weight and caloric intake in a rat model of hypothalamic obesity. Therefore, the investigators hypothesize exenatide treatment might lead to weight loss in hypothalamic obese patients and improve their glycemic control.
- Conditions
- Hypothalamic Obesity, Diabetes Mellitus
- Being tested
- Exenatide
- Medical subject headings
- Sexual Infantilism, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Byetta
5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Exenatide | Experimental | 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight frome baseline to end of the study.
Measured: 3 months
BMI
Measured: baseline and 3 months
HbA1c
Measured: baseline and 3 months
Blood glucose level.
Measured: 3 months.
Beta cell function.
Measured: baseline and 3 months
Insulin sensitivity.
Measured: baseline and 3 months
Secondary outcomes (7)
Waistline
Measured: baseline and 3 months
Ratio of body fat
Measured: baseline and 3 months
The amount of daily energy intake
Measured: baseline and 3 months
Resting energy expenditure (kcals per day)
Measured: baseline and 3 months
Grade of metabolic equivalents (MET) scales
Measured: baseline and 3 months
Hipline.
Measured: baseline and 3 months
waistline/hipline ratio
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2015 (estimated)
- Study completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic ObesityStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoyun Zhang, Huashan Hospital
- Investigators
- Li yi ming, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783717
- Sponsor's protocol ID
- 2012-217
- Status last verified
- Oct 2013
- First submitted
- 25 Dec 2012
- Last updated
- 22 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exenatide on Obesity and/or Diabetes Mellitus Due to Hypothalamic Damage
- ClinicalTrials.gov ID
- NCT01783717
- Acronym / sponsor ID
- 2012-217
- Conditions
- Hypothalamic Obesity, Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jul 2015 (estimated)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients with hypothalamus lesion caused by tumors in the hypothalamic region, such as craniopharyngioma and germ cell tumors, and inflammatory diseases are susceptible to develop severe obesity and diabetes mellitus. The occurrence of hypothalamic obesity in patients after surgery with or without radiotherapy for craniopharyngioma can be as high as 42-66%, and the incidence of type 2 diabetes mellitus of them is twice as much as healthy controls. Treatment of obesity and diabetes mellitus in this population is crucial for increasing morbidity and mortality. However, diet and exercise intervention has been proven useless in previous studies. Safe and effective medicine remains to be developed. Exenatide, a GLP-1 receptor agonist, which play an antihyperglycemic role through a variety of mechanisms, such as enhancing glucose-dependent insulin secretion, increasing beta cell mass and decreasing glucagon secretion, possesses a potent ability to induce satiety, slow gastric emptying and reduce food intake, resulting in weight loss both in diabetics and patients with simple obesity. Previous animal study has already shown GLP-1 agonist exendin-4 leads to reduction of weight and caloric intake in a rat model of hypothalamic obesity. Therefore, the investigators hypothesize exenatide treatment might lead to weight loss in hypothalamic obese patients and improve their glycemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exenatide | Experimental | Drug: Exenatide5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Byetta5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks | Drug | Exenatide |
Primary outcome
Change in body weight frome baseline to end of the study.
Time frame: 3 months
BMI
Time frame: baseline and 3 months
HbA1c
Time frame: baseline and 3 months
Blood glucose level.
Time frame: 3 months.
Beta cell function.
Time frame: baseline and 3 months
Insulin sensitivity.
Time frame: baseline and 3 months
7 secondary outcomes
Waistline
Time frame: baseline and 3 months
Ratio of body fat
Time frame: baseline and 3 months
The amount of daily energy intake
Time frame: baseline and 3 months
Resting energy expenditure (kcals per day)
Time frame: baseline and 3 months
Grade of metabolic equivalents (MET) scales
Time frame: baseline and 3 months
Hipline.
Time frame: baseline and 3 months
waistline/hipline ratio
Time frame: baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang z yun contact
Li yi ming principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide in people with Hypothalamic Obesity and Diabetes Mellitus, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhang z yun (86-21-52888286), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight frome baseline to end of the study. (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2013.