Type 1 Diabetes Clinical Trial
Official title:
Glucagon Efficiency After High and Low Carbohydrate Diet
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.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label
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