Pituitary AdenomaNCT02574793
Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects
An observational study of Pituitary Adenoma, run by Huashan Hospital at 1 site in China.
Trial summary
Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2014to 7 Jan 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome
Who may be able to join
- •newly diagnosed GH-releasing pituitary adenoma
- •newly diagnosed Cushing Syndrome
Who cannot join
- •history of diabetes mellitus and being treated with drugs
- •being treated with drugs which affect glucose metabolism in the lately 3 months
- •with other hormones affecting glucose metabolism secreted abnormally by pituitary
- •serious comorbidity like malignant tumour, severe hepatosis or nephropathy, serious hypertension(blood pressure> 180/110mmhg)
- •pregnant or breastfeeding women
- •patients allergic to patches or metal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects
Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of the study is to investigate the characteristics of glucose fluctuations in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.
Read the detailed description
Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. Compared with traditional monitoring methods, continuous glucose monitoring system(CGMS) techniques provides a much more detailed understanding of shifting blood glucose levels throughout the day.It is considered reliable to evaluate glucose variability not only in patients with diabetes but also in nondiabetic individuals.
People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism and developing diabetes mellitus.Some researchers have shown that 15-30% Growth Hormone-Secreting Pituitary Adenoma are suffering from diabetes, 15-36% impaired glucose regulation. The rate of Cushing Syndrome individuals is 10-30% and 40-45% separately.
Glycemic variability is poorly studied in the nondiabetic individuals and has not been studied in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals. In this study CGM was used to dynamically monitor patients being newly diagnosed with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome.
- Conditions
- Pituitary Adenoma
- Being tested
- continuous glucose monitoring
- Keywords
- Glucose Fluctuation, GH-Secreting Adenoma, Cushing Syndrome
- Medical subject headings
- Pituitary Neoplasms, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous glucose monitoringDevice
Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous glucose profiles of mean data of 24-hour continuous glucose monitoring by the CGMS Gold
The monitoring results consisted of one curve and 5 parameters
Measured: 3 days
Secondary outcomes (4)
The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients
The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients during the 3 days monitored by CGMS Gold
Measured: 3 days
The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold
The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold
Measured: 3 days
The correlation of MAGE and IGF-1 in newly diagnosed GH adenoma patients
By compared with the outcomes after treated by SSAs or surgery we want to get weather there is a correlation between MAGE and IGF-1 in GH adenoma patients
Measured: 6 months
The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients
By compared with the outcomes after treated by surgery we want to get weather there is a correlation between MAGE and cortison in Cushing Syndrome patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study start1 Dec 2014
- Primary completion31 Dec 2017
- Study completion7 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiaolong zhao, Huashan Hospital
- Investigators
- yiming li, Study director, director of the endocrinology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574793
- Sponsor's protocol ID
- KY2015-152
- Status last verified
- Dec 2014
- First submitted
- 9 Oct 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects
- ClinicalTrials.gov ID
- NCT02574793
- Acronym / sponsor ID
- KY2015-152
- Conditions
- Pituitary Adenoma
- Keywords
- Glucose Fluctuation, GH-Secreting Adenoma, Cushing Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 7 Jan 2018 (actual)
- First posted
- 14 Oct 2015 (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.
Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism. Glycemic variability is poorly studied in the nondiabetic individuals. The aim of the study is to investigate the characteristics of glucose fluctuations in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals.
Detailed description
Glucose fluctuations present not only in patients with diabetes mellitus but also in subjects with normal glucose tolerance or impaired glucose regulation. Compared with traditional monitoring methods, continuous glucose monitoring system(CGMS) techniques provides a much more detailed understanding of shifting blood glucose levels throughout the day.It is considered reliable to evaluate glucose variability not only in patients with diabetes but also in nondiabetic individuals.
People with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome are at risk of impaired glucose metabolism and developing diabetes mellitus.Some researchers have shown that 15-30% Growth Hormone-Secreting Pituitary Adenoma are suffering from diabetes, 15-36% impaired glucose regulation. The rate of Cushing Syndrome individuals is 10-30% and 40-45% separately.
Glycemic variability is poorly studied in the nondiabetic individuals and has not been studied in the newly diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome individuals. In this study CGM was used to dynamically monitor patients being newly diagnosed with Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome
Key inclusion criteria (2 listed)
- •newly diagnosed GH-releasing pituitary adenoma
- •newly diagnosed Cushing Syndrome
Key exclusion criteria (6 listed)
- •history of diabetes mellitus and being treated with drugs
- •being treated with drugs which affect glucose metabolism in the lately 3 months
- •with other hormones affecting glucose metabolism secreted abnormally by pituitary
- •serious comorbidity like malignant tumour, severe hepatosis or nephropathy, serious hypertension(blood pressure> 180/110mmhg)
- •pregnant or breastfeeding women
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 |
|---|---|---|
| continuous glucose monitoringPatients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold. | Device | – |
Primary outcome
Continuous glucose profiles of mean data of 24-hour continuous glucose monitoring by the CGMS Gold
Time frame: 3 days
The monitoring results consisted of one curve and 5 parameters
4 secondary outcomes
The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients
Time frame: 3 days
The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold
Time frame: 3 days
The correlation of MAGE and IGF-1 in newly diagnosed GH adenoma patients
Time frame: 6 months
The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Related trials for Pituitary Adenoma
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
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.
yiming li study director
director of the endocrinology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary Adenoma, 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 23 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous glucose profiles of mean data of 24-hour continuous glucose monitoring by the CGMS Gold (time frame: 3 days). 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 23 Jan 2018.