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

NCT02574793 | Completed DMC

• 1 other identifier: KY2015-152
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Keywords

Glucose Fluctuation; GH-Secreting Adenoma; Cushing Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• The mean amplitude of glycemic excursion of newly diagnosed GH adenoma patients

  3 days

• 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

  6 months

• The correlation of MAGE and cortison in newly diagnosed Cushing Syndrome patients

  6 months

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Xiaolong Zhao

Jing’an, Shanghai Municipality, 20041, China

Location

MeSH Terms

Conditions

Pituitary Neoplasms; Cushing Syndrome

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• yiming li

  director of the endocrinology department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Associate Professor of Endocrinology department

Study Record Dates

• First Submitted: October 9, 2015
• First Posted: October 14, 2015
• Study Start: December 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: January 7, 2018
• Last Updated: January 23, 2018

Record last verified: 2014-12

Locations

CN (1)