- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04098549
The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes (RaSlo-19)
24. juni 2020 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
10
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Gentofte, Danmark, 2820
- Steno Diabetes Center Copenhagen
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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Eksperimentel: 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.
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Rapid lowering of plasma glucose using hypoglycemic clamp technique
Slow lowering of plasma glucose using hypoglycemic clamp technique
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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
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from 0-120 minutes after glucagon administration
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Total area under the glucose curve (AUC)
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Peak plasma glucose
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Incremental plasma glucose peak
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Time-to-peak plasma glucose
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Plasma glucose level
Tidsramme: 120 minutes after glucagon administration
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120 minutes after glucagon administration
|
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Duration of plasma glucose above 4.0 mmol/l
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of plasma glucose above baseline
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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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)
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throughout phase 4 (until 120 minutes after glucagon administration)
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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)
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throughout phase 4 (until 120 minutes after glucagon administration)
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Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-10 mmol/l
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Change in insulin levels (measured as area under the curve)
Tidsramme: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in insulin levels (measured as peak change)
Tidsramme: from baseline to 120 minutes after glucagon administration
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from baseline to 120 minutes after glucagon administration
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Change in glucagon levels (measured as area under the curve)
Tidsramme: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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Change in glucagon levels (measured as peak change)
Tidsramme: 0-120 minutes after glucagon administration
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0-120 minutes after glucagon administration
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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
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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
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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
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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
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Number of subjects experiencing vomiting
Tidsramme: from 0-120 minutes after glucagon administration
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from 0-120 minutes after glucagon administration
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
12. september 2019
Primær færdiggørelse (Faktiske)
15. januar 2020
Studieafslutning (Faktiske)
15. januar 2020
Datoer for studieregistrering
Først indsendt
11. september 2019
Først indsendt, der opfyldte QC-kriterier
20. september 2019
Først opslået (Faktiske)
23. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. juni 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2020
Sidst verificeret
1. juni 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- H-19034585
Plan for individuelle deltagerdata (IPD)
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Ja
IPD-deling Understøttende informationstype
- Studieprotokol
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