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NCT Number: NCT02574793

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Xiaolong Zhao

Jing’an, Shanghai Municipality, 20041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Oct 14, 2015
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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