Glucagon Efficiency After High and Low Carbohydrate Diet

Phase 4

Completed

• Conditions: Type 1 Diabetes; Hypoglycemia
• Interventions: Dietary Supplement: Low carbohydrate intake; Dietary Supplement: High carbohydrate intake

• Registration Number: NCT02578498
• Lead Sponsor: Hvidovre University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-14
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-19
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Last Update Submitted: 2016-08-15
• Last Update Posted: 2016-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age 18 - 70 years
• 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

• Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High carbohydrate diet	Low carbohydrate intake	high carbohydrate intake
Low carbohydrate diet	High carbohydrate intake	low carbohydrate intake

Primary Outcome Measures

Name	Time	Method
Incremental area under the glucose curve	0-240 minutes
Peak glucose value	within 240 minutes

Secondary Outcome Measures

Name	Time	Method
Plasma glucose variation	Two weeks	A continuous glucose monitor register daily glucose variation levels for two weeks.
Katekolamine concentration	0-240 min.	Blood samples
Headache	0-240 min.	Visual analog scale
Glucagon concentration	0-240 min.	Blood samples
Ketone bodies concentration	0-240 min.	Blood samples
Hypoglycemia symptoms	0-240 min.	Visual analog scale
Vomit	0-240 min.	Occurence
Insulin concentration	0-240 min.	Blood samples
Triglycerides concentration	0-240 min.	Blood samples
Nausea	0-240 min.	Visual analog scale
Free fatty acids concentration	0-240 min.

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark