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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02578498
Other study ID # H-15009662
Secondary ID
Status Completed
Phase Phase 4
First received October 14, 2015
Last updated August 15, 2016
Start date October 2015
Est. completion date July 2016

Study information

Verified date October 2015
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date July 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
High carbohydrate intake
Carbohydrate intake < 50 gram
Low carbohydrate intake
Carbohydrate intake > 250 gram

Locations

Country Name City State
Denmark Hvidovre University Hospital Hvidovre

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital Danish Diabetes Academy

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incremental area under the glucose curve 0-240 minutes No
Primary Peak glucose value within 240 minutes Yes
Secondary Glucagon concentration Blood samples 0-240 min. No
Secondary Insulin concentration Blood samples 0-240 min. No
Secondary Triglycerides concentration Blood samples 0-240 min. No
Secondary Katekolamine concentration Blood samples 0-240 min. No
Secondary Ketone bodies concentration Blood samples 0-240 min. No
Secondary Free fatty acids concentration 0-240 min. No
Secondary Nausea Visual analog scale 0-240 min. Yes
Secondary Headache Visual analog scale 0-240 min. No
Secondary Hypoglycemia symptoms Visual analog scale 0-240 min. No
Secondary Vomit Occurence 0-240 min. Yes
Secondary Plasma glucose variation A continuous glucose monitor register daily glucose variation levels for two weeks. Two weeks Yes
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