DiabetesNCT05290207
The Different Response of Endocrine Hormones to Hypoglycemia in Patients With Type 1 or Type 2 Diabetes
An observational study of Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- The hyperinsulinaemic hypoglycaemic clamp
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2022to 16 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Normal subjects and newly diagnosed male patients with type 1 or type 2 diabetes
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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
- Conditions
- Diabetes
- Being tested
- The hyperinsulinaemic hypoglycaemic clamp
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The hyperinsulinaemic hypoglycaemic clampDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed male obese patients with type 2 diabetes | Not described Receives: Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp | |
| Newly diagnosed male non-obese patients with type 2 diabetes | Not described Receives: Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp | |
| Newly diagnosed male patients with type 1 diabetes | Not described Receives: Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp | |
| Healthy, non-obese men | Not described Receives: Diagnostic Test: The hyperinsulinaemic hypoglycaemic clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
endocrine hormone changes
changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start6 Jan 2022
- Primary completion16 Sep 2022
- Study completion16 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-hua Ma, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290207
- Sponsor's protocol ID
- KY20220124-07
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 31 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41306512
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Endocrine Hormone Changes in Newly Diagnosed Patients With Type 2 and Type 1 Diabetes Using Hyperinsulinaemic Hypoglycaemic Clamp Technique
- ClinicalTrials.gov ID
- NCT05290207
- Acronym / sponsor ID
- KY20220124-07
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 16 Sep 2022 (actual)
- Study completion
- 16 Sep 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Normal subjects and newly diagnosed male patients with type 1 or type 2 diabetes
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The hyperinsulinaemic hypoglycaemic clampGlucose will be clamped at 5.0 mmol/L for approximately 30 minutes, and then be lowered to 3.0 mmol/L for 30 minutes | Diagnostic test | 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 |
Primary outcome
endocrine hormone changes
Time frame: 20 minutes
changes of endocrine hormones during hyperinsulinaemic hypoglycaemic clamps
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Derived from this study: PubMed 41306512Zhou 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endocrine hormone changes (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05290207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.