- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01870713
Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus
Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently,researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures.
This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Henan
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Luoyang, Henan, Kina, 471000
- No. 150 Central hospital of Chinese People's Liberation Army
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
- age:18-65yr
- HbAlc>8%
Exclusion Criteria:
- diabetes (applies for control patients)
- chronic inflammatory disease
- malignant disease
- pregnancy
- prior gastric, duodenal, proximal jejunal surgery or pancreas resection
- current use of thiazolidinediones
- treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
- HbAlc<8%
- any condition felt by the investigator to interfere with ability to complete the study
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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type 2 diabetes patients with gastric bypass surgery.
Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery.
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Weight matched non-operated controls
Participants who are overweight to moderately obese, and have no personal of family history of Type 1, Type 2, or Gestational Diabetes.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.
Tidsramme: base line to 3 months
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base line to 3 months
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.
Tidsramme: 1 year
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1 year
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 150CTSX001
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