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

NCT ID: NCT05290207

Last Updated: 2023-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-06

Study Completion Date

2022-09-16

Brief Summary

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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

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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

Conditions

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Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Newly diagnosed male obese patients with type 2 diabetes

The hyperinsulinaemic hypoglycaemic clamp

Intervention Type 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

Newly diagnosed male non-obese patients with type 2 diabetes

The hyperinsulinaemic hypoglycaemic clamp

Intervention Type 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

Newly diagnosed male patients with type 1 diabetes

The hyperinsulinaemic hypoglycaemic clamp

Intervention Type 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

The hyperinsulinaemic hypoglycaemic clamp

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jian-hua Ma

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nanjing First Hospital, Nanjing Medical Univesity

Nanjing, , China

Site Status

Countries

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China

Other Identifiers

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KY20220124-07

Identifier Type: -

Identifier Source: org_study_id

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