- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01863147
Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong predictor of cardiovascular events and all-cause mortality .
Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430070
- Wuhan General Hospital
-
Wuhan, Hubei, Kina, 430070
- Guangda Xiang
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:Patients had to have the levels of hemoglobin A1c (HbA1c) > 7.0 %. They also had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. In addition, they were also required to have an office BP < 135/85 mm Hg and the presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index [LVMI] > 115 g/m2 for men and > 95 g/m2 for women) . -
Exclusion Criteria:Patients were excluded if they were currently prescribed glucagon-like peptide (GLP) -1 analogues or DPP-4 inhibitors or glucosidase inhibitor or anti-hypertensive drugs (including b-blockers), diabetes medications, estrogen supplements, thyroxine, diuretics, hypolipidemic drugs. They were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women. -
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Sitagliptin
Sitagliptin 0.1 daily for 1 year
|
Sitagliptin group: The intervention drug is sitagliptin.
Acarbose group: The intervention drug is acarbose.
|
Aktiv komparator: acarbose
acarbose 150mg daily for 1 year
|
Sitagliptin group: The intervention drug is sitagliptin.
Acarbose group: The intervention drug is acarbose.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Left ventricular mass and left ventricular volume
Tidsramme: 2013~2014(follow up 1 year)
|
Cardiac magnetic resonance (CMR) imaging was performed at baseline and at 12 months for left ventricular mass and left ventricular volume.
|
2013~2014(follow up 1 year)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Endothelial function and augmentation index (AIx)
Tidsramme: 2013~2014 (follow up 1 year)
|
|
2013~2014 (follow up 1 year)
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Xiang Guangda, MD,PhD, Wuhan General Hospital of Guangzhou Command
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Karsygdomme
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Åreforkalkning
- Arterielle okklusive sygdomme
- Sygdomme i det endokrine system
- Diabetes mellitus
- Koronararteriesygdom
- Myokardieiskæmi
- Koronar sygdom
- Diabetes mellitus, type 2
- Hypoglykæmiske midler
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Proteasehæmmere
- Inkretiner
- Dipeptidyl-Peptidase IV-hæmmere
- Glycosidhydrolasehæmmere
- Sitagliptin fosfat
- Acarbose
Andre undersøgelses-id-numre
- 2010Wze052
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