Glucagon Efficiency After High and Low Carbohydrate Diet

NCT02578498 | Completed Phase 4

• 1 other identifier: H-15009662
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes; Hypoglycemia

Keywords

glucagon; Carbohydrate diet

Outcome Measures

Primary Outcomes (2)

• Incremental area under the glucose curve

  0-240 minutes

• Peak glucose value

  within 240 minutes

Secondary Outcomes (11)

• Glucagon concentration

  0-240 min.

• Insulin concentration

  0-240 min.

• Triglycerides concentration

  0-240 min.

• Katekolamine concentration

  0-240 min.

• Ketone bodies concentration

  0-240 min.

Study Arms (2)

High carbohydrate diet

PLACEBO COMPARATOR

high carbohydrate intake

Dietary Supplement: Low carbohydrate intake

Low carbohydrate diet

ACTIVE COMPARATOR

low carbohydrate intake

Dietary Supplement: High carbohydrate intake

Interventions

High carbohydrate intake DIETARY_SUPPLEMENT

Carbohydrate intake \< 50 gram

Low carbohydrate diet

Low carbohydrate intake DIETARY_SUPPLEMENT

Carbohydrate intake \> 250 gram

High carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• Danish Diabetes Academy: collaborator

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Ranjan A, Schmidt S, Damm-Frydenberg C, Steineck I, Clausen TR, Holst JJ, Madsbad S, Norgaard K. Low-Carbohydrate Diet Impairs the Effect of Glucagon in the Treatment of Insulin-Induced Mild Hypoglycemia: A Randomized Crossover Study. Diabetes Care. 2017 Jan;40(1):132-135. doi: 10.2337/dc16-1472. Epub 2016 Oct 21.

  PMID: 27797928 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kirsten Nørgaard, MD, DMSc

  Hvidovre University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 16, 2016

Record last verified: 2015-10

Locations

DK (1)