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

May 29, 2023 updated by: Jian-hua Ma, Nanjing First Hospital, Nanjing Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Nanjing, China
        • Nanjing First Hospital, Nanjing Medical Univesity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Newly diagnosed male obese patients with type 2 diabetes
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
Newly diagnosed male non-obese patients with type 2 diabetes
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
Newly diagnosed male patients with type 1 diabetes
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
Healthy, non-obese men
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endocrine hormone changes
Time Frame: 20 minutes
changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing First Hospital, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2022

Primary Completion (Actual)

September 16, 2022

Study Completion (Actual)

September 16, 2022

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 29, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20220124-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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