Type 1 DiabetesPhase 4HiLoCarbNCT02578498
Glucagon Efficiency After High and Low Carbohydrate Diet
A Phase 4 study testing High carbohydrate intake and Low carbohydrate intake in people with Type 1 Diabetes and Hypoglycemia, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- High carbohydrate intake and Low carbohydrate intake
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to Jul 2016
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years
- T1D ≥ 3 year
- BMI 20-27 kg/m2
- CSII ≥ 1 year
- HbA1c < 69 mmol/mol (8.5 %)
- C-peptide negative (< 60 pmol/l)
- Hypoglycemia awareness (self-reported)
- Use of carbohydrate counting and the insulin pump bolus calculator for all meals
Who cannot join
- Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- 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 study start
- Known or suspected alcohol or drug abuse
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- Inability to understand the patient information and to give informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia.
HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content.
Read more
AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions.
DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- High carbohydrate intake, Low carbohydrate intake
- Keywords
- glucagon, Carbohydrate diet
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High carbohydrate intakeDietary supplement
Carbohydrate intake < 50 gram
Low carbohydrate intakeDietary supplement
Carbohydrate intake > 250 gram
| Study group | Role | What they receive |
|---|---|---|
| High carbohydrate diet | Placebo comparator | high carbohydrate intake Receives: Dietary Supplement: Low carbohydrate intake |
| Low carbohydrate diet | Active comparator | low carbohydrate intake Receives: Dietary Supplement: High carbohydrate intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area under the glucose curve
Measured: 0-240 minutes
Peak glucose value
Measured: within 240 minutes
Secondary outcomes (11)
Glucagon concentration
Blood samples
Measured: 0-240 min.
Insulin concentration
Blood samples
Measured: 0-240 min.
Triglycerides concentration
Blood samples
Measured: 0-240 min.
Katekolamine concentration
Blood samples
Measured: 0-240 min.
Ketone bodies concentration
Blood samples
Measured: 0-240 min.
Free fatty acids concentration
Measured: 0-240 min.
Nausea
Visual analog scale
Measured: 0-240 min.
Headache
Visual analog scale
Measured: 0-240 min.
Hypoglycemia symptoms
Visual analog scale
Measured: 0-240 min.
Vomit
Occurence
Measured: 0-240 min.
Plasma glucose variation
A continuous glucose monitor register daily glucose variation levels for two weeks.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionJul 2016
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 Type 1 DiabetesStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Diabetes Academy
- Responsible party
- Principal investigator, Ajenthen Ranjan, Hvidovre University Hospital
- Investigators
- Kirsten Nørgaard, MD, DMSc, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578498
- Sponsor's protocol ID
- H-15009662
- Acronym
- HiLoCarb
- Status last verified
- Oct 2015
- First submitted
- 14 Oct 2015
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Ranjan A, Schmidt S, Damm-Frydenberg C, Steineck I, Clausen TR, Holst JJ, Madsbad S, Norgaard K. Low-Carbohydrate Diet Impairs the Effect of Glucagon in the Treatment of Insulin-Induced Mild Hypoglycemia: A Randomized Crossover Study. Diabetes Care. 2017 Jan;40(1):132-135. doi: 10.2337/dc16-1472. Epub 2016 Oct 21.
PubMed 27797928
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucagon Efficiency After High and Low Carbohydrate Diet
- ClinicalTrials.gov ID
- NCT02578498
- Acronym / sponsor ID
- HiLoCarb / H-15009662
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- glucagon, Carbohydrate diet
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Danish Diabetes Academy
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 19 Oct 2015 (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.
No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia.
HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content.
AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions.
DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High carbohydrate diet | Placebo comparator | Dietary Supplement: Low carbohydrate intakehigh carbohydrate intake |
| Low carbohydrate diet | Active comparator | Dietary Supplement: High carbohydrate intakelow carbohydrate intake |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 70 years
- T1D ≥ 3 year
- BMI 20-27 kg/m2
- CSII ≥ 1 year
- HbA1c < 69 mmol/mol (8.5 %)
Key exclusion criteria (8 listed)
- Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
- Impaired renal function (eGFR < 60 ml/min/1.73m2)
- Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- 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 study start
- Known or suspected alcohol or drug abuse
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 |
|---|---|---|
| High carbohydrate intakeCarbohydrate intake < 50 gram | Dietary supplement | Low carbohydrate diet |
| Low carbohydrate intakeCarbohydrate intake > 250 gram | Dietary supplement | High carbohydrate diet |
Primary outcome
Incremental area under the glucose curve
Time frame: 0-240 minutes
Peak glucose value
Time frame: within 240 minutes
11 secondary outcomes
Glucagon concentration
Time frame: 0-240 min.
Insulin concentration
Time frame: 0-240 min.
Triglycerides concentration
Time frame: 0-240 min.
Katekolamine concentration
Time frame: 0-240 min.
Ketone bodies concentration
Time frame: 0-240 min.
Free fatty acids concentration
Time frame: 0-240 min.
Nausea
Time frame: 0-240 min.
Headache
Time frame: 0-240 min.
Hypoglycemia symptoms
Time frame: 0-240 min.
Vomit
Time frame: 0-240 min.
Plasma glucose variation
Time frame: Two weeks
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 16 Aug 2016.
- Derived from this study: PubMed 27797928Ranjan A, Schmidt S, Damm-Frydenberg C, Steineck I, Clausen TR, Holst JJ, Madsbad S, Norgaard K. Low-Carbohydrate Diet Impairs the Effect of Glucagon in the Treatment of Insulin-Induced Mild Hypoglycemia: A Randomized Crossover Study. Diabetes Care. 2017 Jan;40(1):132-135. doi: 10.2337/dc16-1472. Epub 2016 Oct 21.
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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.
Kirsten Nørgaard, MD, DMSc study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High carbohydrate intake and Low carbohydrate intake in people with Type 1 Diabetes and Hypoglycemia, run by Hvidovre University Hospital 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 8 inclusion and 8 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 16 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incremental area under the glucose curve (time frame: 0-240 minutes). The study lists 2 primary outcomes in all. 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 NCT02578498, 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 16 Aug 2016.