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

Completed

• Conditions: Diabetes
• Interventions: Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp

• Registration Number: NCT05290207
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2022-01-06
• Status Verified: 2022-03
• Study First Submitted: 2022-03-17
• Study First Submitted QC: 2022-03-20
• Study First Posted: 2022-03-22
• Primary Completion: 2022-09-16
• Study Completion: 2022-09-16
• Last Update Submitted: 2023-05-29
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Newly diagnosed male obese patients with type 2 diabetes	The hyperinsulinaemic hypoglycaemic clamp	-
Newly diagnosed male patients with type 1 diabetes	The hyperinsulinaemic hypoglycaemic clamp	-
Newly diagnosed male non-obese patients with type 2 diabetes	The hyperinsulinaemic hypoglycaemic clamp	-
Healthy, non-obese men	The hyperinsulinaemic hypoglycaemic clamp	-

Primary Outcome Measures

Name	Time	Method
endocrine hormone changes	20 minutes	changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps

Trial Locations

Locations (1)

Nanjing First Hospital, Nanjing Medical Univesity; 🇨🇳 Nanjing, China