The Different Response of Endocrine Hormones to Hypoglycemia in Patients With Type 1 or Type 2 Diabetes

Diabetes Clinical Trial

Official title:

A Study of Endocrine Hormone Changes in Newly Diagnosed Patients With Type 2 and Type 1 Diabetes Using Hyperinsulinaemic Hypoglycaemic Clamp Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290207
• Other study ID #: KY20220124-07
• Status: Completed
• Start date: January 6, 2022
• Est. completion date: September 16, 2022

Study information

• Verified date: March 2022
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Endocrine hormones, not only blood glucose responsive hormones, but also sexual hormones, thyroid hormones, growth hormones and so on, may have response and activites in hypoglycemia. However, the different responses of endocrine hormones to hypoglycemia in patients With diabetes remain unclear.

Description:

This study will observe the changes of insulin, C-peptide, glucagon, growth hormone, IGF-1, ACTH, cortisol, thyroid function, sexual hormone in newly diagnosed men with type 2 and type 1 diabetes mellitus using hyperinsulinaemic hypoglycaemic clamp technique

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 16, 2022
• Est. primary completion date: September 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients

• newly diagnosed male patients with type 1 or type 2 diabetes (diagnostic criteria of World Health Organization)

• aged 18-50 years

• has not been treated with any hypoglycemic drugs

• HbA1c>9% Normal subjects: healthy and had no known illness

Exclusion Criteria:

• patients with insulin allergy.

• any history of hypoglycemic agent intake or were presently taking hypoglycemic agents

• any abnormality in liver or kidney function on blood and urine investigations

• any history of systemic corticosteroid use in 3 months

• any recent infections or acute medical events

• any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Diagnostic Test:
• The hyperinsulinaemic hypoglycaemic clamp
Glucose will be clamped at 5.0 mmol/L for approximately 30 minutes, and then be lowered to 3.0 mmol/L for 30 minutes

Locations

Country	Name	City	State
China	Nanjing First Hospital, Nanjing Medical Univesity	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	endocrine hormone changes	changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps	20 minutes