Glycemic Fluctuations in Newly Diagnosed Growth Hormone-S... | NCT02574793

Studies
Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

NCT02574793

Sponsor

Huashan Hospital

Status

Completed

Last Update Posted

Jan 23, 2018Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pituitary Adenoma

Interventions

continuous glucose monitoring

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2014Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jan 7, 2018Actual

First Submitted Date

Oct 9, 2015

First Submission Date that Met QC Criteria

Oct 10, 2015

First Posted Date

Oct 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2018

Last Update Posted Date

Jan 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

xiaolong zhao, Principal Investigator, Clinical Associate Professor of Endocrinology department, Huashan HospitalPrincipal Investigator

Lead Sponsor

Huashan HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
continuous glucose monitoring	Device	Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	3 days

Secondary Outcomes

Measure	Description	Time Frame
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	3 days
The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

•newly diagnosed GH-releasing pituitary adenoma
•newly diagnosed Cushing Syndrome

Exclusion Criteria:

•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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
yiming li	director of the endocrinology department	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xiaolong Zhao		Jing’an	Shanghai Municipality	20041	China

Condition Browse Module

MeSH Terms

ID	Term
D010911	Pituitary Neoplasms
D003480	Cushing Syndrome

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D007029	Hypothalamic Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000095583	Continuous Glucose Monitoring

Ancestor Terms

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided