Clinical trial NCT02882737: The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
Official title: The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus
Conditions: Type 1 Diabetes Mellitus
Summary: This project is part of several studies exploring situations, where glucagon potential has lesser glucose elevating effect. Exercise can be one of these situations as exercise may reduce liver glycogen depots.
The investigators aims are:
1. To compare the increase in plasma glucose after 200µg glucagon given either after exercise or after resting for 45 minutes.
2. To determine whether a subcutaneous glucagon injection just before exercise has a greater impact on hepatic glucose production and thereby is superior to an injection after exercise in preventing hypoglycemia during and two hours after exercise.
3. To compare the accuracy of two Dexcom G4 continuous glucose monitors, (CGM) placed at either the abdominal wall or on the upper arm.
Interventions:
name: Glucagon before exercise
type: Drug
name: Glucagon after exercise
type: Drug
name: Glucagon after resting
type: Drug
Study arms:
design_group_description: 120 minutes after breakfast; a single subcutaneous bolus of 200µg glucagon is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered.<br/>Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve.<br/>When exercise is ended a single subcutaneous bolus of 0.2 ml saline is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered.
design_group_title: Exercise and glucagon before exercise
design_group_type: Experimental
design_group_description: 120 minutes after breakfast; a single subcutaneous bolus of 0.2 ml saline is administered by the primary investigator. However, the patient do, not know whether placebo or a glucagon injection is administered.<br/>Exercise: Immediately thereafter, the patient will bicycle for 45 minutes at 50% of the heart rate HR reserve.<br/>Low-dose glucagon phase: When exercise is ended or when hypoglycemia occurs (≤3.9 mmol/l); a single subcutaneous bolus of 200μg glucagon is administered and the exercise session will be suspended. Again, the patient do not know whether placebo or a glucagon is administered.
design_group_title: Exercise and glucagon after exercise
design_group_type: Active Comparator
design_group_description: 120 minutes after breakfast; a single subcutaneous bolus of 200μg placebo is administered.<br/>Resting: After placebo injection the patient will be resting on a hospital bed for 45 minutes. The patient do not know if placebo or glucagon is administered.<br/>Low-dose glucagon phase: After 45 minutes of resting or when hypoglycemia occurs, a single subcutaneous bolus of 200μg glucagon is administered.<br/>Safety issues: If plasma glucose drops < 2.5 mmol/l at two consecutive measurements with 5 min interval or the patient experiences unbearable symptoms of hypoglycemia even after glucagon administration, 20 g carbohydrate is given orally. If plasma glucose drops< 2.3 mmol/l or doesn't raise sufficient after oral glucose, we will give intravenøs glucose to the patient. The study will then end and a new study day will be planned.
design_group_title: Resting and glucagon after resting
design_group_type: Active Comparator
Sponsor: Hvidovre University Hospital
Collaborators: Technical University of Denmark
Drug name mappings:
name: 胰高血糖素
lang: CN
name: Glucagon
lang: EN
name: グルカゴン
lang: JP