New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases; most of the remainder achieve better glycemic control, even if they regain weight. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.
Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.
This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
- Fas 3
Kontakter och platser
Studieorter
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SP
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Campinas, SP, Brasilien
- LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Obesity grade I (BMI 30-34,9)
- Weight variance less than 5% in the last 3 months.
- Previous diagnosis of diabetes type 2.
- Insulin requirement, alone or along with oral agents
- Capacity to understand the procedures of the study.
- To agree voluntarily to participate of the study, signing an informed consent.
Exclusion Criteria:
- Positive Anti-GAD antibodies
- Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
- History of hepatic disease like cirrhosis or chronic active hepatitis.
- Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
- Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
- Recent history of neoplasia (< 5 years).
- Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 1
Roux-en-Y bypass gastroplasty
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Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch.
A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm.
A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Förbättring eller upphävande av typ 2-diabetes mellitus
Tidsram: 7 dagar, 14 dagar, 21 dagar, 1 månad, 2 månader, 3 månader, sex månader och ett år.
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7 dagar, 14 dagar, 21 dagar, 1 månad, 2 månader, 3 månader, sex månader och ett år.
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Förändringar i kroppsvikt och fettfördelning efter intervention
Tidsram: 1 månad, 2 månader, 3 månader, 6 månader och 1 år
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1 månad, 2 månader, 3 månader, 6 månader och 1 år
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Regression av carotis intima-media tjocklek
Tidsram: 1 månad, 3 månader, 6 månader och 1 år
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1 månad, 3 månader, 6 månader och 1 år
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Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test
Tidsram: 6 months and 1 year
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6 months and 1 year
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Improvement of insulin sensitivity as measured by insulin tolerance test
Tidsram: 1 month, 3 months, 6 months and 1 year
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1 month, 3 months, 6 months and 1 year
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Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines
Tidsram: one month, 2 months, 3 months, 6 months and 1 year
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one month, 2 months, 3 months, 6 months and 1 year
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Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography
Tidsram: 1 year and 2 years
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1 year and 2 years
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Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography
Tidsram: 1 year and 2 years
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1 year and 2 years
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Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection
Tidsram: 6 months, 1 year and 2 years
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6 months, 1 year and 2 years
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: José Carlos Pareja, MD, PhD, University of Campinas (UNICAMP)
- Huvudutredare: Bruno Geloneze, MD, PhD, University of Campinas (UNICAMP)
Publikationer och användbara länkar
Allmänna publikationer
- Pories WJ, Swanson MS, MacDonald KG, Long SB, Morris PG, Brown BM, Barakat HA, deRamon RA, Israel G, Dolezal JM, et al. Who would have thought it? An operation proves to be the most effective therapy for adult-onset diabetes mellitus. Ann Surg. 1995 Sep;222(3):339-50; discussion 350-2. doi: 10.1097/00000658-199509000-00011.
- Pories WJ, MacDonald KG Jr, Flickinger EG, Dohm GL, Sinha MK, Barakat HA, May HJ, Khazanie P, Swanson MS, Morgan E, et al. Is type II diabetes mellitus (NIDDM) a surgical disease? Ann Surg. 1992 Jun;215(6):633-42; discussion 643. doi: 10.1097/00000658-199206000-00010.
- Geloneze B, Tambascia MA, Pilla VF, Geloneze SR, Repetto EM, Pareja JC. Ghrelin: a gut-brain hormone: effect of gastric bypass surgery. Obes Surg. 2003 Feb;13(1):17-22. doi: 10.1381/096089203321136539.
- Geloneze B, Tambascia MA, Pareja JC, Repetto EM, Magna LA. The insulin tolerance test in morbidly obese patients undergoing bariatric surgery. Obes Res. 2001 Dec;9(12):763-9. doi: 10.1038/oby.2001.105.
- Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. doi: 10.1097/01.sla.0000102990.47956.98.
- Fellici AC, Lambert G, Lima MM, Pareja JC, Rodovalho S, Chaim EA, Geloneze B. Surgical treatment of type 2 diabetes in subjects with mild obesity: mechanisms underlying metabolic improvements. Obes Surg. 2015 Jan;25(1):36-44. doi: 10.1007/s11695-014-1377-9.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- LIMED0004
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