Glucagon Efficiency After High and Low Carbohydrate Diet

Type 1 Diabetes Clinical Trial

— HiLoCarb  

Official title:

Glucagon Efficiency After High and Low Carbohydrate Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02578498
• Other study ID #: H-15009662
• 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

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

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