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| Name | Class |
|---|---|
| Danish Diabetes Academy | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High carbohydrate diet | Placebo Comparator | high carbohydrate intake |
|
| Low carbohydrate diet | Active Comparator | low carbohydrate intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High carbohydrate intake | Dietary Supplement | Carbohydrate intake < 50 gram |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental area under the glucose curve | 0-240 minutes | |
| Peak glucose value | within 240 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon concentration | Blood samples | 0-240 min. |
| Insulin concentration | Blood samples | 0-240 min. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirsten Nørgaard, MD, DMSc | Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hvidovre University Hospital | Hvidovre | 2650 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27797928 | Derived | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Low carbohydrate intake |
| Dietary Supplement |
Carbohydrate intake > 250 gram |
|
| Triglycerides concentration | Blood samples | 0-240 min. |
| Katekolamine concentration | Blood samples | 0-240 min. |
| Ketone bodies concentration | Blood samples | 0-240 min. |
| Free fatty acids concentration | 0-240 min. |
| Nausea | Visual analog scale | 0-240 min. |
| Headache | Visual analog scale | 0-240 min. |
| Hypoglycemia symptoms | Visual analog scale | 0-240 min. |
| Vomit | Occurence | 0-240 min. |
| Plasma glucose variation | A continuous glucose monitor register daily glucose variation levels for two weeks. | Two weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |