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Metabolic Effects of Gastrointestinal Surgery in T2DM

Metabolic Effects of Duodenal-jejunal Bypass Surgery in Non Morbidly Obese Subjects With Type 2 Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01771185
Enrollment
24
Registered
2013-01-18
Start date
2012-10-31
Completion date
2013-12-31
Last updated
2013-01-18

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

Conditions

Type 2 Diabetes

Keywords

Diabetes, metabolic surgery, insulin resistance

Brief summary

Gastric bypass surgery resolves type 2 diabetes mellitus (T2DM) without the need for diabetes therapy in \ 80% of patients. Moreover, improvement in insulin sensitivity and glucose homeostasis occurs within days after surgery before significant weight loss is achieved. This observation has led to the notion that bypassing the upper gastrointestinal (GI) tract has specific therapeutic effects on insulin action and glucose metabolism. In fact, both surgical and endoscopic procedures that bypass the upper GI tract are currently being studied in human subjects. Recently, a new surgical technique, duodenal-jejunal bypass surgery (DJBS), has been developed specifically to treat T2DM. Data from preliminary studies have shown that DJBS results in glycemic control in 87% of overweight and obese patients with T2DM.These subjects will undergo metabolic studies at the University Hospital in Sao Paulo before and after their surgical procedure. Washington University investigators will: 1) provide technical support and guidance to the physicians performing the studies in Brazil, 2) process and analyze blood samples obtained from the study at the Washington University Center for Human Nutrition, and 3) be involved in analyzing the data and writing the final manuscripts. The effects of DJBS on the following clinical and metabolic parameters will be evaluated

Interventions

PROCEDUREDuodenal jejunal bypass plus sleeve gastrectomy

Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy

DRUGBest medical treatment (Metformin ; gliclazide)

Metformin 2 g/day; gliclazide 30 mg

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Uncontrolled diabetes ( A1c\>8%) * Less than 10 years of history * Not taking insulin * Ages between 20 and 65 years old * BMI between 26-34

Exclusion criteria

* previous abdominal surgery * LADA * Using insulin

Design outcomes

Primary

MeasureTime frameDescription
Hb A1a24 moPrimary endpoints- glycemic control

Secondary

MeasureTime frame
Systolic and diastolic blood pressure control24 mo
fasting glycemic control24 months
Lipidic control24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026