- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01600703
Sitagliptin Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans
20. januar 2017 opdateret af: University Health Network, Toronto
Sitagliptin (®Januvia) Regulation of Intestinal and Hepatic Lipoprotein Particle and Hepatic Glucose Production in Humans
Recent studies in both animals and humans has demonstrated that the hormone GLP-1 (glucagon like peptide 1) reduces intestinal production of lipoprotein particles.
The investigators therefore hypothesise that the drug sitagliptin which prevents the breakdown of GLP-1 will reduce intestinal lipoprotein production in humans.
The investigators are unable to speculate whether sitagliptin will affect hepatic lipoprotein production because of lack of of data from animal studies or in vitro data.
Sitagliptin is already an approved treatment for type 2 diabetes.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study.
In study A they will receive a single dose of sitagliptin 100mg od.
In study B they will receive placebo.
A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the study.
On the day of the study regular liquid formula (Great shake plus) will be infused from 4am through the tube to maintain a constant fed state.
A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) along with saline/sitagliptin will be started at 7am.
From 9am an iv bolus of deuterated-glycerol (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3].
Regular blood samples will be drawn to assess lipoprotein kinetics.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Ontario
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Toronto, Ontario, Canada, M5G 2C4
- Toronto General Hospital
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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 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Men and women, aged 18 to 60 years
- Body mass index 20 kg/m2 to 27 kg/m2
- Hemoglobin above 130g/L.
- Normal glucose tolerance in response to a 75g, 2-hr OGTT
Exclusion Criteria:
- Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180) or proliferative retinopathy
- History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
- Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
- Any laboratory values: AST > 2x ULN; ALT > 2x ULN TSH > 6 mU/l
- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Taking any prescription or non-prescription medications at the time of the study
- Having donated blood three months prior to and three months post study procedures
- A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.
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 |
---|---|
Eksperimentel: Sitagliptin
sitagliptin, 100mg, oral, single dose
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Sitagliptin, 100mg, oral, single dose
Andre navne:
|
Placebo komparator: Placebo
Placebo, oral, single dose
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Placebo, oral, single dose
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Apolipoprotein B48 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)
Tidsramme: 10 hours
|
Apolipoprotein B48 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates.
Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.
|
10 hours
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Apolipoprotein B100 Production Rate After Acute Oral Administration of 100mg Sitagliptin (Compared to Placebo)
Tidsramme: 10 hours
|
Apolipoprotein B100 turnover was measured in a 10-hour kinetic study with in vivo tracer techniques and mathematical modeling to calculate production rates.
Studies were performed under conditions of a pancreatic clamp and a steady state fed state in volunteers receiving single oral dose of either 100mg sitagliptin or matching placebo.
|
10 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gary Lewis, MD, UHN
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. juli 2012
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. august 2013
Datoer for studieregistrering
Først indsendt
15. maj 2012
Først indsendt, der opfyldte QC-kriterier
16. maj 2012
Først opslået (Skøn)
17. maj 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
23. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. januar 2017
Sidst verificeret
1. januar 2013
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Lipidmetabolismeforstyrrelser
- Dyslipidæmi
- Hyperlipidæmi
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Sitagliptin fosfat
Andre undersøgelses-id-numre
- Sitagliptin-REB-09-0428-B
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Sitagliptin
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Emory UniversityMerck Sharp & Dohme LLCAfsluttet
-
Baylor College of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetType 1 diabetesForenede Stater
-
Shahid Beheshti University of Medical SciencesIsfahan University of Medical SciencesAfsluttet
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Afsluttet
-
Samsung Medical CenterJW PharmaceuticalAfsluttetType 2 diabetes mellitusKorea, Republikken
-
University of Colorado, DenverMerck Sharp & Dohme LLCAfsluttetKardiovaskulær sygdom | Type 2 diabetesForenede Stater
-
National Institute on Aging (NIA)Afsluttet
-
University Hospital Inselspital, BerneFresenius KabiAfsluttetUnderernæring | Gastrointestinale tumorerSchweiz
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Beijing Chao Yang HospitalRekruttering
-
Eurofarma Laboratorios S.A.AfsluttetDiabetes mellitus, type 2Brasilien