New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

• Register: ClinicalTrials.gov
• Last refreshed on: 11 March 2013
• Main ID: NCT00566189
• Date of registration: 30/11/2007
• Primary sponsor: University of Campinas, Brazil
• Public title: New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
• Scientific title: New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
• Date of first enrolment: August 2007
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00566189
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Brazil

Contacts

• Name: Bruno Geloneze, MD, PhD
• Affiliation: University of Campinas (UNICAMP)

• Name: José Carlos Pareja, MD, PhD
• Affiliation: University of Campinas (UNICAMP)

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Insulin Resistance

Obesity

Intervention(s)

Procedure: Roux-en-Y Bypass Gastroplasty

Primary Outcome(s)

Improvement or reversal of type 2 diabetes mellitus [Time Frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.]

Secondary Outcome(s)

Changes in body weight and fat distribution after intervention [Time Frame: 1 month, 2 months, 3 months, 6 months and 1 year]

Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines [Time Frame: one month, 2 months, 3 months, 6 months and 1 year]

Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test [Time Frame: 6 months and 1 year]

Improvement of insulin sensitivity as measured by insulin tolerance test [Time Frame: 1 month, 3 months, 6 months and 1 year]

Regression of carotid intima-media thickness [Time Frame: 1 month, 3 months, 6 months and 1 year]

Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography [Time Frame: 1 year and 2 years]

Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography [Time Frame: 1 year and 2 years]

Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection [Time Frame: 6 months, 1 year and 2 years]

Secondary ID(s)

LIMED0004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethicon Endo-Surgery