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CompletedNCT05290207Updated May 31, 2023

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

An observational study in Diabetes, sponsored by Nanjing First Hospital, Nanjing Medical University. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-31.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
35
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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

02

Conditions studied

  • Diabetes

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03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 35 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
35 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testThe 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

06

What researchers measure

Primary outcomes

  1. endocrine hormone changes

    changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps

    Time frame: 20 minutes

07

Study locations

1 site
  • Nanjing First Hospital, Nanjing Medical Univesity
    Nanjing, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05290207
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Jian-hua Ma (Professor, Nanjing First Hospital, Nanjing Medical University) — Principal investigator
First posted
Mar 22, 2022
Start date
Jan 6, 2022
Primary completion
Sep 16, 2022
Completion
Sep 16, 2022
Last update
May 31, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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