Phase 2 Completed N=22 Treatment

Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

Type 2 Diabetes · Obesity

Source: ClinicalTrials.gov NCT00791128 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Dec 2016

Primary outcomePrimary: % of Excess Weight Loss (EWL) — 37.7 % excess weight loss

Summary

The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

Outcome Measures

Outcome	Result	p-value
PRIMARY % of Excess Weight Loss (EWL)	37.7	—
SECONDARY HbA1c Values at 12 Months	6.6	—

Eligibility Criteria

Inclusion Criteria

Age 18 to 65
BMI 40 to 60
Type II Diabetes
Candidates for bariatric surgery

Exclusion Criteria

Patients with

hepatitis B or C
gastroesophageal reflux disease (GERD)
HIV Positive diagnosis
pancreatitis
conditions of gastrointestinal tract, such as ulcers or Crohn's
an infection or who are H. Pylori positive

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00791128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.