Clinical trial NCT02574793: Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects
Official title: Characteristics of Glycemic Fluctuations in Newly Diagnosed Growth Hormone-Secreting Pituitary Adenoma and Cushing Syndrome Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Keywords: Glucose Fluctuation
GH-Secreting Adenoma
Cushing Syndrome
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome

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.

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

Primary outcomes:
measure: Continuous glucose profiles of mean data of 24-hour continuous glucose monitoring by the CGMS Gold
timeFrame: 3 days
Secondary outcomes:
measure: The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients
timeFrame: 3 days
measure: The mean amplitude of glycemic excursion of newly diagnosed Cushing Syndrome patients during the 3 days monitored by CGMS Gold
timeFrame: 3 days
measure: The correlation of MAGE and IGF-1 in newly diagnosed GH adenoma patients
timeFrame: 6 months
measure: The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients
timeFrame: 6 months
Other outcomes:
Locations:
city: Jing'an
country: China
facility: Xiaolong Zhao
state: Shanghai
Study officials:
affiliation: director of the endocrinology department
name: yiming li
role: STUDY_DIRECTOR
References: