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

NCT05290207 | Completed

• 1 other identifier: KY20220124-07
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• endocrine hormone changes

  changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps

  20 minutes

Study Arms (4)

Newly diagnosed male obese patients with type 2 diabetes

Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp

Newly diagnosed male non-obese patients with type 2 diabetes

Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp

Newly diagnosed male patients with type 1 diabetes

Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp

Healthy, non-obese men

Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp

Interventions

The hyperinsulinaemic hypoglycaemic clamp DIAGNOSTIC_TEST

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

Healthy, non-obese men; Newly diagnosed male non-obese patients with type 2 diabetes; Newly diagnosed male obese patients with type 2 diabetes; Newly diagnosed male patients with type 1 diabetes

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Normal subjects and newly diagnosed male patients with type 1 or type 2 diabetes

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

Location

Related Publications (1)

• Zhou Y, Zhou J, Ma J, Yan R, Yuan L, Huang R, Shen Y, Ding B. Comparative Evaluation of Responsiveness of Insulin Counter-Regulatory Hormones and Insulin Resistance to Hypoglycemia in Newly Diagnosed Type 1 Diabetes Mellitus Man. Diabetes Metab Syndr Obes. 2025 Nov 21;18:4309-4317. doi: 10.2147/DMSO.S554306. eCollection 2025.

  PMID: 41306512 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 22, 2022
• Study Start: January 6, 2022
• Primary Completion: September 16, 2022
• Study Completion: September 16, 2022
• Last Updated: May 31, 2023

Record last verified: 2022-03

Locations

CN (1)