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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2015 by xiaolong zhao, Huashan Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02574793
First Posted: October 14, 2015
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
xiaolong zhao, Huashan Hospital
  Purpose
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.

Condition Intervention
Pituitary Adenoma Device: continuous glucose monitoring

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects

Resource links provided by NLM:


Further study details as provided by xiaolong zhao, Huashan Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 GH adenoma 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 [ Time Frame: 3 days ]
    The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold

  • The correlation of MAGE and IGF-1 in newly diagnosed GH adenoma patients [ Time Frame: 6 months ]
    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

  • The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients [ Time Frame: 6 months ]
    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


Estimated Enrollment: 60
Study Start Date: December 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: continuous glucose monitoring
    Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574793


Contacts
Contact: xiaolong zhao, MD 86-18918067241 xiaolongzhao@163.com

Locations
China, Shanghai
Xiaolong Zhao Recruiting
Jing'an, Shanghai, China, 20041
Contact: xiaolong zhao    86-18918067241    xiaolongzhao@163.com   
Sponsors and Collaborators
Huashan Hospital
Investigators
Study Director: yiming li director of the endocrinology department
  More Information

Responsible Party: xiaolong zhao, Principal Investigator, Clinical Associate Professor of Endocrinology department, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02574793     History of Changes
Other Study ID Numbers: KY2015-152
First Submitted: October 9, 2015
First Posted: October 14, 2015
Last Update Posted: October 14, 2015
Last Verified: October 2015

Keywords provided by xiaolong zhao, Huashan Hospital:
Glucose Fluctuation
GH-Secreting Adenoma
Cushing Syndrome

Additional relevant MeSH terms:
Adenoma
Pituitary Diseases
Cushing Syndrome
Pituitary Neoplasms
Growth Hormone-Secreting Pituitary Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs