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NCT Number: NCT02578498

Glucagon Efficiency After High and Low Carbohydrate Diet

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High carbohydrate intake

Dietary Supplement

Carbohydrate intake < 50 gram

Low carbohydrate intake

Dietary Supplement

Carbohydrate intake > 250 gram

Primary outcomes

  1. Incremental area under the glucose curve

    Time frame: 0-240 minutes

  2. Peak glucose value

    Time frame: within 240 minutes

Secondary outcomes

  1. Glucagon concentration

    Time frame: 0-240 min.

    Blood samples

  2. Insulin concentration

    Time frame: 0-240 min.

    Blood samples

  3. Triglycerides concentration

    Time frame: 0-240 min.

    Blood samples

  4. Katekolamine concentration

    Time frame: 0-240 min.

    Blood samples

  5. Ketone bodies concentration

    Time frame: 0-240 min.

    Blood samples

  6. Free fatty acids concentration

    Time frame: 0-240 min.

  7. Nausea

    Time frame: 0-240 min.

    Visual analog scale

  8. Headache

    Time frame: 0-240 min.

    Visual analog scale

  9. Hypoglycemia symptoms

    Time frame: 0-240 min.

    Visual analog scale

  10. Vomit

    Time frame: 0-240 min.

    Occurence

  11. Plasma glucose variation

    Time frame: Two weeks

    A continuous glucose monitor register daily glucose variation levels for two weeks.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Danish Diabetes Academy

Registry information

Acronym: HiLoCarb

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2015
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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