HypoglycemiaNCT03034226
Comparison Between Hypoglycemic Counter Regulatory Responses in Type 1 Diabetics vs Control Subjects
A study testing Glucose clamp technique in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoglycemia, Diabetes Mellitus, Type 1
- What is being tested?
- Glucose clamp technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2017to 1 Jan 2019
- Phase
- Interventional
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- More than 5 years of disease duration
- HbA1c 42-86 mmol/L
- No known HAAF
- BMI 22-28
- Written consent
- BMI 22-28
- Written consent
Who cannot join
- Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance
- Medication f.x beta-blockade, steroids, psychotropics
- Smoking
- Drug abuse
- Control subjects
- Diseases f.x diabetes, epilepsy, ischemic heart disease or heart rhythm disturbance
Show all 9Show fewer
- Medication f.x beta-blockade, steroids, psychotropics
- Smoking
- Drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia
Read the detailed description
Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- Glucose clamp technique
- Keywords
- Hypoglycemia-Associated Autonomic Failure (HAAF)
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose clamp techniqueOther
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
| Study group | Role | What they receive |
|---|---|---|
| Single episode of hypoglycemia | Active comparator | Day 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours Receives: Other: Glucose clamp technique |
| Two episodes of hypoglycemia | Active comparator | Day 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours Receives: Other: Glucose clamp technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Insulin sensitivity before, during hypoglycemia and after recovery from hypoglycemia on day 2 (one episode of hypoglycemia) compared with day 4 (two consecutive episodes of hypoglycemia). Insulin sensitivity is measured as M-value derived from the Glucose Infusion Rate (GIR) during a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
Measured: Day 2 and day 4 (T=60 minutes - T=240 minutes)
Secondary outcomes (2)
Hormonal counter regulatory response to hypoglycemia
Hormonal counter regulatory response (epinephrine, norepinephrine, glucagon, cortisol, ghrelin etc.) measured regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
Measured: Day 2 and day 4 (T=0 minutes, T=30, T=40, T=50, T=120, T=130, T=140, T160, T=170, T=180, T=210, T=220, T=230, T=390, T=400 and T=410
Symptoms during hypoglycemia
Using the Edinburgh Hypoglycemia Scale (symptom scale) we will interview the subjects regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
Measured: Day 2 and day 4 (T=0 minutes - T=420 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start23 Feb 2017
- Primary completion1 Feb 2018
- Study completion1 Jan 2019
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 HypoglycemiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 9 diabetic subjects and 9 healthy control subjects will be randomized to undergo either first day 1 + day 2 (two consecutive episode of hypoglycemia) or first day 3 + day 4 (one episode of hypoglycemia).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mads Bisgaard Bengtsen, MD, phd student, Principal investigator, Department of Endocrinology and Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03034226
- Sponsor's protocol ID
- Project 1-10-72-304-16
- Status last verified
- Mar 2018
- First submitted
- 17 Jan 2017
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bengtsen MB, Stoy J, Rittig NF, Voss TS, Magnusson NE, Svart MV, Jessen N, Moller N. A Human Randomized Controlled Trial Comparing Metabolic Responses to Single and Repeated Hypoglycemia in Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa645. doi: 10.1210/clinem/dgaa645.
PubMed 32927476
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Counter Regulatory Responses in Type 1 Diabetic Patients Versus Healthy Control Subjects With and Without Antecedent Hypoglycemia
- ClinicalTrials.gov ID
- NCT03034226
- Acronym / sponsor ID
- Project 1-10-72-304-16
- Conditions
- Hypoglycemia, Diabetes Mellitus, Type 1
- Keywords
- Hypoglycemia-Associated Autonomic Failure (HAAF)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 27 Jan 2017 (estimated)
- 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.
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia
Detailed description
Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 9 diabetic subjects and 9 healthy control subjects will be randomized to undergo either first day 1 + day 2 (two consecutive episode of hypoglycemia) or first day 3 + day 4 (one episode of hypoglycemia).
| Arm | Type | Receives |
|---|---|---|
| Single episode of hypoglycemia | Active comparator | Other: Glucose clamp techniqueDay 1: Hyperinsulinemic hypoglycemic clamp 30 min Day 2: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours |
| Two episodes of hypoglycemia | Active comparator | Other: Glucose clamp techniqueDay 3: No intervention (normal blood glucose) Day 4: Hyperinsulinemic euglycemic clamp and hyperinsulinemic hypoglycemic clamp 7 hours |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- More than 5 years of disease duration
- HbA1c 42-86 mmol/L
- No known HAAF
- BMI 22-28
- Written consent
Key exclusion criteria (9 listed)
- Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance
- Medication f.x beta-blockade, steroids, psychotropics
- Smoking
- Drug abuse
- Control subjects
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 |
|---|---|---|
| Glucose clamp techniqueHyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose | Other | Single episode of hypoglycemia, Two episodes of hypoglycemia |
Primary outcome
Insulin sensitivity
Time frame: Day 2 and day 4 (T=60 minutes - T=240 minutes)
Insulin sensitivity before, during hypoglycemia and after recovery from hypoglycemia on day 2 (one episode of hypoglycemia) compared with day 4 (two consecutive episodes of hypoglycemia). Insulin sensitivity is measured as M-value derived from the Glucose Infusion Rate (GIR) during a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp
2 secondary outcomes
Hormonal counter regulatory response to hypoglycemia
Time frame: Day 2 and day 4 (T=0 minutes, T=30, T=40, T=50, T=120, T=130, T=140, T160, T=170, T=180, T=210, T=220, T=230, T=390, T=400 and T=410
Symptoms during hypoglycemia
Time frame: Day 2 and day 4 (T=0 minutes - T=420 minutes)
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 5 Oct 2022.
- Derived from this study: PubMed 32927476Bengtsen MB, Stoy J, Rittig NF, Voss TS, Magnusson NE, Svart MV, Jessen N, Moller N. A Human Randomized Controlled Trial Comparing Metabolic Responses to Single and Repeated Hypoglycemia in Type 1 Diabetes. J Clin Endocrinol Metab. 2020 Dec 1;105(12):dgaa645. doi: 10.1210/clinem/dgaa645.
- 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.
Mads Bisgaard Bengtsen, MD, phd student principal investigator
Department of Endocrinology and Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose clamp technique in people with Hypoglycemia and Diabetes Mellitus, Type 1, run by University of Aarhus at 1 site in Denmark.
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 7 inclusion and 9 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 5 Oct 2022. 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 Denmark. 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?
Insulin sensitivity (time frame: Day 2 and day 4 (T=60 minutes - T=240 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 NCT03034226, 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 5 Oct 2022.