Insulin Secretion in Healthy, in Obese and in Obese Type 2 Diabetic Patients Undergoing Bariatric Surgery

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-9kdzdv
• Date of registration: 01/03/2013
• Primary sponsor: Universidade Estadual de Campinas - Campinas, SP, Brazil
• Public title: Insulin Secretion in Healthy, in Obese and in Obese Type 2 Diabetic Patients Undergoing Bariatric Surgery
• Scientific title: Insulin Secretory Capacity in Healthy, in Obese, and in Obese Type 2 Diabetic Patients Undergoing Bariatric Surgery Through the Hyperglycemic Clamp
• Date of first enrolment: 01/01/2010
• Target sample size: 60
• Recruitment status: recruitment completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-9kdzdv/
• Study design: Nonrandomized clinical trial, parallel, with three arms

Countries of recruitment

Brazil

Contacts

• Name: Bruno Geloneze
• Affiliation: Universidade Estadual de Campinas

• Name: Bruno Geloneze
• Affiliation: Universidade Estadual de Campinas

Key inclusion & exclusion criteria

Inclusion criteria: Female, older than 20 years, being in premenopausal period, type 2 diabetic patient using only oral anti-diabetic medication or no medication for diabetes, weight variation less than 5% in the last 3 months; capacity to understand the procedures of the study and voluntarily agree to participate in the study by signing the consent form.
Exclusion criteria: Patients taking insulin or drugs with effects on insulin secretion; BMI greater than or equal to 18.5 kg / m²; history of liver disease such as cirrhosis or chronic active hepatitis; alteration of renal function, a recent history of cancer, use of oral corticosteroids or injected by more than 14 consecutive days in the last 3 months.

Age minimum: 20Y
Age maximum: 60Y
Gender: F

Health Condition(s) or Problem(s) studied

E00-E90

Type 2 diabetes. Beta-cell Dysfunction. Bariatric Surgery.
C18.452.394.750.149

Intervention(s)

Controlled study: one experimental group and two control groups. Experimental group: 20 obese grade I and II patients with type 2 diabetes who underwent biliopancreatic diversion surgery. Evaluated preoperatively, in the first month and in the twelfth month after surgery. Eutrophic control group: 20 normal weight and normal glucose tolerant women which were not subjected to any intervention. Evaluated only once. Obese control group: 20 obese grade I and II normal glucose tolerant women which were not subjected to any intervention. Evaluated only once.

Primary Outcome(s)

Acute improvement on beta-cell function one month after biliopancreatic diversion surgery assessed by hyperglycemic clamp test and by the oral glucose tolerance test

Secondary Outcome(s)

Improvement on beta-cell function one year after biliopancreatic diversion surgery assessed by hyperglycemic clamp test and by the oral glucose tolerance test

Secondary ID(s)

0568.0.146.000-08

Parecer CEP: 708/2008

Source(s) of Monetary Support

Fundação de Amparo à Pesquisa do Estado de São Paulo - FAPESP - São Paulo, SP, Brazil

Secondary Sponsor(s)

Universidade Estadual de Campinas - Campinas, SP, Brazil