Diabetes Mellitus, Type 1NCT03734718
The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes
A study testing GIP in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 1, Hypoglycemia
- What is being tested?
- GIP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2019to 31 Dec 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body mass index between 20 and 27 kg/m2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Treatment with a stable insulin regimen ≥3 months
- T1D duration between 2 and 15years
- C-peptide negative (C-peptide ≤ 16 ng/ml)
- Informed consent
Who cannot join
- Anemia (hemoglobin outside normal range)
- Known liver disease and/or ALAT and/or ASAT > 2 times normal values
- Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
- Prior Cardiovascular events and/or abnormal heart rate/blood pressure
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
- Any physical or psychological condition that the investigator feels would interfere with trial participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology
Hellerup, 2800
About this study
Official title: The Role of Glucose-dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis of Type 1 Diabetes
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia
- Being tested
- GIP
- Keywords
- Gastric Inhibitory Polypeptide, Diabetes Mellitus, Type 1, Hypoglycemia, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Glucagon, Incretin
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIPDrug
Infusion of Glucose-dependent insulinotropic peptide
| Study group | Role | What they receive |
|---|---|---|
| Glucose-Dependent Insulinotropic Polypeptide | Active comparator | 6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide Receives: Drug: GIP |
| Placebo | Placebo comparator | Saline Receives: Drug: GIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Time spent in hypoglycemia, near-normoglycemia and hyperglycemia
Measured: an average of 6 days
Secondary outcomes (8)
Incretin hormones
Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve
Measured: Evaluated at experimental day 0,1 and 6 of each intervention
Free fatty acids (FFA)
Incremental and total area under the Concentration-Time Curve
Measured: Evaluated at experimental day 0,1 and 6 of each intervention
Fat mRNA
mRNA analysis of fat biopsies
Measured: At day 6, and 10 of the study
Fat Protein content
Protein analysis of fat biopsies
Measured: Evaluated at experimental day 0,1 and 6 of each intervention
Blood pressure
Changes in blood pressure, mm Hg
Measured: The first 24 hours of intervention and at experimental day 6
Pulse
Changes in pulse, beats per minute
Measured: The first 24 hours of intervention and at experimental day 6
Glucose regulatory hormones
Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve
Measured: Evaluated at experimental day 0,1 and 6 of each intervention
Number of symptomatic hypoglycemic events
Self-reported events
Measured: An average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jun 2019
- Primary completion12 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- placebo-controlled, double-blinded, cross-over study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734718
- Sponsor's protocol ID
- GIPHOT
- Other IDs
- H-18015379
- Status last verified
- Jan 2020
- First submitted
- 22 Oct 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.
PubMed 40004948Heimburger SMN, Hoe B, Nielsen CN, Bergman NC, Skov-Jeppesen K, Hartmann B, Holst JJ, Dela F, Overgaard J, Storling J, Vilsboll T, Dejgaard TF, Havelund JF, Gorshkov V, Kjeldsen F, Faergeman NJ, Madsen MR, Christensen MB, Knop FK. GIP Affects Hepatic Fat and Brown Adipose Tissue Thermogenesis but Not White Adipose Tissue Transcriptome in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3261-3274. doi: 10.1210/clinem/dgac542.
PubMed 36111559Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17.
PubMed 34405256
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Glucose-dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03734718
- Acronym / sponsor ID
- GIPHOT
- Conditions
- Diabetes Mellitus, Type 1, Hypoglycemia
- Keywords
- Gastric Inhibitory Polypeptide, Diabetes Mellitus, Type 1, Hypoglycemia, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Glucagon, Incretin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 Nov 2018 (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.
In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- placebo-controlled, double-blinded, cross-over study
| Arm | Type | Receives |
|---|---|---|
| Glucose-Dependent Insulinotropic Polypeptide | Active comparator | Drug: GIP6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide |
| Placebo | Placebo comparator | Drug: GIPSaline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body mass index between 20 and 27 kg/m2
- T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c <69 mmol/mol (<8.5%)
- Treatment with a stable insulin regimen ≥3 months
- T1D duration between 2 and 15years
- C-peptide negative (C-peptide ≤ 16 ng/ml)
Key exclusion criteria (6 listed)
- Anemia (hemoglobin outside normal range)
- Known liver disease and/or ALAT and/or ASAT > 2 times normal values
- Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
- Prior Cardiovascular events and/or abnormal heart rate/blood pressure
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
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 |
|---|---|---|
| GIPInfusion of Glucose-dependent insulinotropic peptide | Drug | Glucose-Dependent Insulinotropic Polypeptide, Placebo |
Primary outcome
Blood glucose
Time frame: an average of 6 days
Time spent in hypoglycemia, near-normoglycemia and hyperglycemia
8 secondary outcomes
Incretin hormones
Time frame: Evaluated at experimental day 0,1 and 6 of each intervention
Free fatty acids (FFA)
Time frame: Evaluated at experimental day 0,1 and 6 of each intervention
Fat mRNA
Time frame: At day 6, and 10 of the study
Fat Protein content
Time frame: Evaluated at experimental day 0,1 and 6 of each intervention
Blood pressure
Time frame: The first 24 hours of intervention and at experimental day 6
Pulse
Time frame: The first 24 hours of intervention and at experimental day 6
Glucose regulatory hormones
Time frame: Evaluated at experimental day 0,1 and 6 of each intervention
Number of symptomatic hypoglycemic events
Time frame: An average of 1 week
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 27 Jan 2020.
- Derived from this study: PubMed 40004948Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.
- Derived from this study: PubMed 36111559Heimburger SMN, Hoe B, Nielsen CN, Bergman NC, Skov-Jeppesen K, Hartmann B, Holst JJ, Dela F, Overgaard J, Storling J, Vilsboll T, Dejgaard TF, Havelund JF, Gorshkov V, Kjeldsen F, Faergeman NJ, Madsen MR, Christensen MB, Knop FK. GIP Affects Hepatic Fat and Brown Adipose Tissue Thermogenesis but Not White Adipose Tissue Transcriptome in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3261-3274. doi: 10.1210/clinem/dgac542.
- Derived from this study: PubMed 34405256Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17.
- 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?
A study testing GIP in people with Diabetes Mellitus, Type 1 and Hypoglycemia, run by Steno Diabetes Center Copenhagen 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 6 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 27 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Blood glucose (time frame: an average of 6 days). 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 NCT03734718, which also lists 3 linked publications.
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 27 Jan 2020.