Hvidovre University Hospital
Hvidovre, 2650, Denmark
NCT Number: NCT02578498
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 4
Hvidovre, 2650, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Carbohydrate intake < 50 gram
Carbohydrate intake > 250 gram
Time frame: 0-240 minutes
Time frame: within 240 minutes
Time frame: 0-240 min.
Blood samples
Time frame: 0-240 min.
Blood samples
Time frame: 0-240 min.
Blood samples
Time frame: 0-240 min.
Blood samples
Time frame: 0-240 min.
Blood samples
Time frame: 0-240 min.
Time frame: 0-240 min.
Visual analog scale
Time frame: 0-240 min.
Visual analog scale
Time frame: 0-240 min.
Visual analog scale
Time frame: 0-240 min.
Occurence
Time frame: Two weeks
A continuous glucose monitor register daily glucose variation levels for two weeks.
Hvidovre University Hospital
Other
Acronym: HiLoCarb
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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