Glucagon Efficiency After High and Low Carbohydrate Diet
NCT ID: NCT02578498
Last Updated: 2016-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2015-10-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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High carbohydrate diet
high carbohydrate intake
Low carbohydrate intake
Carbohydrate intake \> 250 gram
Low carbohydrate diet
low carbohydrate intake
High carbohydrate intake
Carbohydrate intake \< 50 gram
Interventions
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High carbohydrate intake
Carbohydrate intake \< 50 gram
Low carbohydrate intake
Carbohydrate intake \> 250 gram
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Danish Diabetes Academy
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
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Ajenthen Ranjan
MD, PhD student
Principal Investigators
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Kirsten Nørgaard, MD, DMSc
Role: STUDY_CHAIR
Hvidovre University Hospital
Locations
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Hvidovre University Hospital
Hvidovre, , Denmark
Countries
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References
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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.
Other Identifiers
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H-15009662
Identifier Type: -
Identifier Source: org_study_id
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