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Effectiveness of Intragastric balloon associated with diet on treatment of patients with type 2 diabetes

Evaluation of Intragastric Balloon effectiveness associated to diet on treatment of diabetic patients with BMI<35 - BMI - Body Mass Index

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3ypfxv
Enrollment
Unknown
Registered
2017-05-04
Start date
2013-04-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional and metabolic diseases Obesity Diabetes Mellitus, Type 2

Interventions

Intragastric balloon will be placed in all 40 patients of the study. After 6 months, the balloon will be removed and the patients will be followed clinically for another 6 months, completing 12 months
Procedure/surgery
E07.430
E01.370.388.250
D06.472.317

Sponsors

Faculdade de Medicina da Univesidade de São Paulo
Lead Sponsor
Fapesp - Fundação de Amparo à Pesquisa do Estado de São Paulo
Collaborator

Eligibility

Age
21 Years to 59 Years

Inclusion criteria

Inclusion criteria: Volunteers males or females, age between 21 and 59 years; Overweight or obesity grade I (BMI between 27 and 34.9); Non-insulin dependent Diabetes Mellitus, glycated hemoglobin 1; Previous esophagogastroduodenoscopy with negative Helicobacter pylori research; Approval of psychological and nutritional profile; Clinical / drug and behavioral treatment directed to overweight patients, with no success; Signed informed consent form.

Exclusion criteria

Exclusion criteria: Contraindications to treatment with intragastric, clinical or endoscopic balloon; Impossibility of strict follow-up.

Design outcomes

Primary

MeasureTime frame
Evaluate the effectiveness of the intragastric balloon in the control of diabetes type 2 verified through the measurement of weight change and the evaluation of hormonal changes and glycemic metabolism from the comparison of weight at 0,3,6 and 9 months, and the comparison of fasting and postprandial levels of glucose, insulin, PYY and GLP-1 before and after the use of intragastric balloon (0 and 6 months)—

Secondary

MeasureTime frame
Control of systemic arterial hypertension and hepatic steatosis, verified by measuring blood pressure and performing pre and post-intervention abdominal ultrasonography from the suspension of medications and liver echographic improvement—

Countries

Brazil

Contacts

Public ContactEduardo;Sílvia de Moura;Reimão Seleti

Faculdade de Medicina da Univesidade de São Paulo;Faculdade de Medicina da Univesidade de São Paulo

eghm@uol.com.br;silvia_mansur@yahoo.com.br551126617579;5511952820002

Outcome results

None listed

Source: REBEC (via WHO ICTRP)