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

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.

Study Overview

• Status: Completed
• Conditions: Pituitary Adenoma
• Intervention / Treatment: Device: continuous glucose monitoring

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Jing'an, Shanghai, China, 20041
      • Xiaolong Zhao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold	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	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	6 months

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Director: yiming li, director of the endocrinology department

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 7, 2018

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 10, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 20, 2018
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Cushing Syndrome; Glucose Fluctuation; GH-Secreting Adenoma
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Adenoma; Pituitary Neoplasms; Pituitary Diseases; Cushing Syndrome; Growth Hormone-Secreting Pituitary Adenoma
• Other Study ID Numbers: KY2015-152