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The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)

24 juni 2020 uppdaterad av: Steno Diabetes Center Copenhagen
In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Danmark
      • Gentofte, Danmark, 2820
        • Steno Diabetes Center Copenhagen

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Age 18-70 years
  • Duration of Type 1 Diabetes ≥ 3 years
  • Insulin pump use > 6 months

Exclusion Criteria:

  • 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
  • Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
  • Use of medications that are known to cause QT interval prolongation
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Females who have different basal insulin pattern depending on their menstrual cycle
  • Inability to understand the individual information and to give informed consent
  • Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Rapid-Slow
This arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
Övrig: Rapid lowering of plasma glucose
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Övrig: Slow lowering of plasma glucose
Slow lowering of plasma glucose using hypoglycemic clamp technique
Experimentell: Slow-Rapid
This arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
Övrig: Rapid lowering of plasma glucose
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Övrig: Slow lowering of plasma glucose
Slow lowering of plasma glucose using hypoglycemic clamp technique

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration

Sekundära resultatmått

Resultatmått
Tidsram
Total area under the glucose curve (AUC)
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Peak plasma glucose
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Incremental plasma glucose peak
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Time-to-peak plasma glucose
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Plasma glucose level
Tidsram: 120 minutes after glucagon administration
120 minutes after glucagon administration
Duration of plasma glucose above 4.0 mmol/l
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of plasma glucose above baseline
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l
Tidsram: throughout phase 4 (until 120 minutes after glucagon administration)
throughout phase 4 (until 120 minutes after glucagon administration)
Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l
Tidsram: throughout phase 4 (until 120 minutes after glucagon administration)
throughout phase 4 (until 120 minutes after glucagon administration)
Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of a plasma glucose level in the range of 3.9-10 mmol/l
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Change in insulin levels (measured as area under the curve)
Tidsram: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in insulin levels (measured as peak change)
Tidsram: from baseline to 120 minutes after glucagon administration
from baseline to 120 minutes after glucagon administration
Change in glucagon levels (measured as area under the curve)
Tidsram: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in glucagon levels (measured as peak change)
Tidsram: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Average changes in Edinburgh Hypoglycemia Scale
Tidsram: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations
Tidsram: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration
Number of subjects experiencing vomiting
Tidsram: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Steno Diabetes Center Copenhagen

Samarbetspartners

University of Copenhagen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 september 2019

Primärt slutförande (Faktisk)

15 januari 2020

Avslutad studie (Faktisk)

15 januari 2020

Studieregistreringsdatum

Först inskickad

11 september 2019

Först inskickad som uppfyllde QC-kriterierna

20 september 2019

Första postat (Faktisk)

23 september 2019

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 juni 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juni 2020

Senast verifierad

1 juni 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H-19034585

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Ja

IPD-delning som stöder informationstyp

  • Studieprotokoll

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Störningar i glukosmetabolism

Kliniska prövningar på Rapid lowering of plasma glucose

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