Glucagon Efficiency After High and Low Carbohydrate Diet (HiLoCarb)

Hvidovre University Hospital

Status and phase

Completed

Phase 4

Conditions

Hypoglycemia

Type 1 Diabetes

Treatments

Dietary Supplement: High carbohydrate intake

Dietary Supplement: Low carbohydrate intake

Study type

Interventional

Funder types

Other

Identifiers

NCT02578498

H-15009662

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.