N/A N=41 Randomized Single-blind Treatment

The Effects of Glycemic Optimization Before Gastric Bypass Surgery

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT01353118 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2022

Primary outcome: Primary: Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission. — 6; 6 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: gastric bypass (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Dec 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite of Fasting Glucose, Glycosylated Haemoglobin c and Rates of Type 2 Diabetes Mellitus Remission.	6; 6	—
SECONDARY A Composite of Microvascular Complications	0; 0	—

Summary

Metabolic surgery such as gastric bypass, gastric banding or sleeve gastrectomy operations can cause rapid and uncontrolled reductions in blood glucose. There is limited information on whether: * metabolic surgery is superior to modern medical care for glycaemic control and type 2 diabetes remission. * metabolic surgery is safe for microvascular complications of Type 2 diabetes * good glycaemic control pre surgery has any effects on the long term glycaemia and complications of type 2 diabetes. This study aims to assess: 1. whether metabolic surgery is better for diabetes control compared to medical treatment. 2. whether metabolic surgery is safe for eye, nerve and kidney complications. 3. whether good sugar control before metabolic surgery improves the long term effects of sugar control and microvascular complications.

Eligibility Criteria

Inclusion Criteria

Adult patients with T2DM and BMI above 35kg/m2
HbA1c ≥ 8.5% and/or the presence of at least one microvascular complication.

Exclusion Criteria

End stage retinopathy, nephropathy or neuropathy.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01353118). 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.