Trial · Interventional

CompletedPhase 4Registry data

Glucagon Efficiency After High and Low Carbohydrate Diet

Short name HiLoCarb

NCTNCT02578498Other idH-15009662

Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status: Completed
Phase: Phase 4
Enrollment: 10 participants (actual)
Sponsor: Hvidovre University Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Oct 2015
Primary completion: Mar 2016
Completion: Jul 2016
First posted: 19 Oct 2015 (estimated)
Last update posted: 16 Aug 2016 (estimated)
Conditions: Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017

Ph 4
HiLoCarb
NCT02578498
Oct 2015 to Jul 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

High carbohydrate intakeDietary supplement
Low carbohydrate intakeDietary supplement

Arms2

Placebo comparator
High carbohydrate diet
high carbohydrate intake
Active comparator
Low carbohydrate diet
low carbohydrate intake

Primary outcomes2

Outcomes the sponsor listed as primary.

Incremental area under the glucose curve
Time frame · 0-240 minutes
Peak glucose value
Time frame · within 240 minutes

Secondary outcomes(11)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

2 results

Low-Carbohydrate Diet Impairs the Effect of Glucagon in the Treatment of Insulin-Induced Mild Hypoglycemia: A Randomized Crossover Study.

Ranjan et al. 2017Diabetes carecited by 53

PMID 27797928DOI 10.2337/dc16-1472PUB-27797928

Full text at the publisher2 results

Publisher page See results (2)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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