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Completed

NCT Number: NCT05290207

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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

Primary outcomes

  1. endocrine hormone changes

    Time frame: 20 minutes

    changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
May 31, 2023

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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