Comparison Between Patients With or Without Diabetes Recovery After Bariatric Surgery

Obesity Clinical Trial

Official title:

Long Term Effects of Bariatric Surgery on Diabetes: Comparison Between Patients With or Without Diabetes Recovery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834938
• Other study ID #: LIMED0005
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: August 9, 2011
• Start date: July 2007
• Est. completion date: July 2010

Study information

• Verified date: August 2011
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

Bariatric surgery can lead to improvement or even resolution of type 2 diabetes in about 80% of patients submitted to Roux-en-Y gastric bypass (RYGP). Otherwise, many patients experienced no resolution of their diabetes despite massive surgical-induced weight loss. There appears to be a variable response to surgery depending on surgical and patient factors. To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Description:

Diabetes reversion is observed after bariatric surgeries even before significant weight loss could explain it, mainly in predominantly malabsorptive procedures (98,9% for biliopancreatic diversion or duodenal switch), followed by those combining malabsorption and gastric restriction (83,7% for Roux-en-Y gastric bypass). Changes in the hormonal communication between the digestive system and the pancreas would explain the antidiabetogenic role of the surgery, so this effect could be obtained in nonobese, diabetic individuals.

To explore potential factors affecting diabetes outcomes after RYGP, this study is proposed to make a description of effects of surgical procedures on incretin, insulin production and sensitivity and a comparison between patients with or without remission of Type 2 Diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2010
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Capacity to understand the procedures of the study.

• To agree voluntarily to participate of the study, signing an informed consent.

• Weight variance less than 5% in the last 3 months.

• Operative group with at least 2 year follow-up.

Exclusion Criteria:

• 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: ALT and/or AST 3x above upper normal limit).

• Recent history of neoplasia (< 5 years).

• Use of oral or injectable for more than consecutive 14 days in the last three months.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes
• Obesity

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Brazil	LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Campinas, Brazil	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Pories WJ. Diabetes: the evolution of a new paradigm. Ann Surg. 2004 Jan;239(1):12-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the endogenous response of incretins, orexins and anorexins to a mixed meal test in obese patients with DM2, in patients with DM2 undergoing RYGB with remission of DM2 and in patients without remission.		2 years after RYGB	No