- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02091323
Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabetes Mellitus
25. januar 2015 oppdatert av: Wu Liangping, Guangzhou General Hospital of Guangzhou Military Command
Effect of Modified Laparoscopic Roux-en-Y Gastric Bypass Surgery on Type 2 Diabetics With Lower Body Mass Index in China
The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM) and a body mass index(BMI)>35kg/m2 is clear.
There are large-scale patients with T2DM in Chinese population and currently about two-thirds of them are lack of adequate blood glucose control.
Asian Chinese have different type of obesity, different style of diet, and a relatively low BMI levels as well.
We assess the feasibility and efficacy of laparoscopic roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into account the differences of body size and diet between the United States & Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China.
Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.
Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.The patients will be followed up for one year after surgery and a comparison would be made between the two groups.
Clinical indicators that reflect the effect of LRYGB are monitored before surgery and 1, 3,6,12 months after surgery.
Complete remission of diabetes was defined by hemoglobin A1c (HbA1c)<6.0%
and Fasting plasma glucose (FPG)<5.6mmol/L.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert beskrivelse
Type 2 diabetes mellitus (T2DM) is well known as a chronic metabolic disease.
As the main manifestation of T2DM , the disorder of glucose metabolism which is due to the gradual dysfunction of pancreatic islet and significant insulin resistance results in many problems and complications associated with T2DM such as hypertension, cardiovascular diseases(CVD), lipid disorders and other complications.
Currently, there are more than 346 million people suffered from T2DM worldwide, among which T2DM accounts for about 90%.
A report published by Chinese diabetes and metabolic syndrome research group in 2010 showed that overall prevalence of diabetes is 9.7% over the age of 20 and the total number of diabetes mellitus has reached 92.4 million in Chinese population and what's worse, more than 15.5 percent of adults are in the pre-diabetic state.
Through traditional diet therapy, exercise, changing lifestyle, and standardized medical treatment have a certain effect on diabetes and its complications, T2DM can't be cured so far.
How to cure diabetes mellitus and improve the quality of life of diabetic patients is a common problem faced by doctors in all countries.
In 1984, Pories et al have found that glucose metabolism indicators significantly improved when he analyzed a report of three-year progress results of obesity patients with T2DM after laparoscopic Roux-en-Y gastric bypass surgery(LRYGB) , thus opening a door to the surgical treatment for diabetes.
Now LRYGB is often performed in Europe and United State, and has been written into the diabetes treatment guidelines by American Diabetes Association in 2009.
The surgical treatment for diabetes is an extension from the surgical treatment for morbid obesity.
So diabetes treatment guidelines in 2014 show that bariatric surgery may be considered for T2DM with a body mass index (BMI) >35 kg/m2, especially if diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy.
However, it also mentioned that small trials have shown benefit in patients with type 2 diabetes mellitus and BMI 30-35 kg/m2 after bariatric surgery.
But it still lacks sufficient evidence for patients with BMI below 30kg/m2.
A survey conducted in Shanghai, China, showed that the prevalence of type 2 diabetes was 9.8%, while the prevalence of obesity was 4.3%.But in the United States, the incidence of type 2 diabetes was 10.9% and the obesity population defined by a BMI ≥30 kg/m2 may account for one third of the total population in 2009-2010.
In addition, patients in Asian countries are mostly abdominal obesity compared with that of patients in the United States and Europe where have different type of obesity.
Taking into account the differences of body size and diet between the United States & Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China.
Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.
Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.
Studietype
Intervensjonell
Registrering (Forventet)
200
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Guangdong
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Guangzhou, Guangdong, Kina, 510010
- Rekruttering
- WU
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Ta kontakt med:
- Liangping Wu
- E-post: drwulp@163.com
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Ta kontakt med:
- Yongtao Huang
- E-post: zsh2014@foxmail.com
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Hovedetterforsker:
- Yongtao Huang
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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 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria: In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose(PG) ≥200 mg/dL(11.1 mmol/L) or fasting plasma glucose (FPG) ≥ 7 .0 mmol / L or Two-hour PG ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test(OGTT) or HbA1c > 6.5% .The study candidates were included if they had any of the following features:
- exclusion of type 1 diabetes mellitus(T1DM) ;
- BMI ≤ 35 kg/㎡ or waist circumference >90cm;
- duration of T2DM less than 15 years ;
- age ≤ 65 years ;
- islet functional reserve :fasting C-peptide (FC-P) normal or more , postprandial two-hour C-peptide response more than 2 times compared with a pre-dinner ;
- poor control of medical treatment ,glycated hemoglobin (HbA1c) ≥ 7 .0%;
- volunteer to accept LRYGB surgery and sign the consent
Exclusion Criteria:
- type 1 diabetes mellitus
- age >65 years
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: BMI<28kg/m2
Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI<28kg/m2 group.
|
With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg.
All LRYGB operations were performed using four trocars.
Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac.
Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.
Andre navn:
|
Annen: control
Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI>28kg/m2 group as well.
|
With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg.
All LRYGB operations were performed using four trocars.
Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac.
Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
fasting plasma glucose(FPG)
Tidsramme: up to 36 months after surgery
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up to 36 months after surgery
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
hemoglobin A1c (HbA1c)
Tidsramme: HbA1c will be monitored preoperatively and at 1,3,6,12 ,24,36months after surgery
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HbA1c will be monitored preoperatively and at 1,3,6,12 ,24,36months after surgery
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Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
weight loss
Tidsramme: weight loss will be monitored preoperatively and at 1,3,6,12,24,36 months after surgery
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weight loss will be monitored preoperatively and at 1,3,6,12,24,36 months after surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cotillard A, Poitou C, Duchateau-Nguyen G, Aron-Wisnewsky J, Bouillot JL, Schindler T, Clement K. Type 2 Diabetes Remission After Gastric Bypass: What Is the Best Prediction Tool for Clinicians? Obes Surg. 2015 Jul;25(7):1128-32. doi: 10.1007/s11695-014-1511-8.
- Luger M, Kruschitz R, Langer F, Prager G, Walker M, Marculescu R, Hoppichler F, Schindler K, Ludvik B. Effects of omega-loop gastric bypass on vitamin D and bone metabolism in morbidly obese bariatric patients. Obes Surg. 2015 Jun;25(6):1056-62. doi: 10.1007/s11695-014-1492-7.
- Torriani M, Oliveira AL, Azevedo DC, Bredella MA, Yu EW. Effects of Roux-en-Y gastric bypass surgery on visceral and subcutaneous fat density by computed tomography. Obes Surg. 2015 Feb;25(2):381-5. doi: 10.1007/s11695-014-1485-6.
- Chen Y, Zeng G, Tan J, Tang J, Ma J, Rao B. Impact of roux-en Y gastric bypass surgery on prognostic factors of type 2 diabetes mellitus: meta-analysis and systematic review. Diabetes Metab Res Rev. 2015 Oct;31(7):653-62. doi: 10.1002/dmrr.2622. Epub 2014 Dec 17.
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
1. mars 2014
Primær fullføring (Forventet)
1. desember 2016
Studiet fullført (Forventet)
1. desember 2017
Datoer for studieregistrering
Først innsendt
12. mars 2014
Først innsendt som oppfylte QC-kriteriene
18. mars 2014
Først lagt ut (Anslag)
19. mars 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. januar 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2015
Sist bekreftet
1. januar 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Lrygb2014
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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