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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 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

10

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Rapid lowering of plasma glucose
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Annen: Slow lowering of plasma glucose
Slow lowering of plasma glucose using hypoglycemic clamp technique
Eksperimentell: 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.
Annen: Rapid lowering of plasma glucose
Rapid lowering of plasma glucose using hypoglycemic clamp technique
Annen: Slow lowering of plasma glucose
Slow lowering of plasma glucose using hypoglycemic clamp technique

Hva måler studien?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Tidsramme
Total area under the glucose curve (AUC)
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Peak plasma glucose
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Incremental plasma glucose peak
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Time-to-peak plasma glucose
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Plasma glucose level
Tidsramme: 120 minutes after glucagon administration
120 minutes after glucagon administration
Duration of plasma glucose above 4.0 mmol/l
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Duration of plasma glucose above baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration
Change in insulin levels (measured as area under the curve)
Tidsramme: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in insulin levels (measured as peak change)
Tidsramme: 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)
Tidsramme: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Change in glucagon levels (measured as peak change)
Tidsramme: 0-120 minutes after glucagon administration
0-120 minutes after glucagon administration
Average changes in Edinburgh Hypoglycemia Scale
Tidsramme: 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
Tidsramme: 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
Tidsramme: from 0-120 minutes after glucagon administration
from 0-120 minutes after glucagon administration

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Steno Diabetes Center Copenhagen

Samarbeidspartnere

University of Copenhagen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. september 2019

Primær fullføring (Faktiske)

15. januar 2020

Studiet fullført (Faktiske)

15. januar 2020

Datoer for studieregistrering

Først innsendt

11. september 2019

Først innsendt som oppfylte QC-kriteriene

20. september 2019

Først lagt ut (Faktiske)

23. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. juni 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juni 2020

Sist bekreftet

1. juni 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H-19034585

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-deling Støtteinformasjonstype

  • Studieprotokoll

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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