We hypothesize that laparoscopic RYGB surgery is more effective on glycaemic control than conventional therapy in moderate obese patients with BMI 30 * 35 kg/m2 .
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Gastrointestinal therapeutic procedures
Synonym
Health condition
Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete remission of DM2 defined as FPG < 5.6 mmol/L and HbA1c < 6.0% (<42
mmol/mol) without anti-diabetic medication for minimal 1 year
Secondary outcome
Improvement of HbA1c: HbA1c difference of 1% (or 11 mmol/mol; SD 1.5% or 16.5
mmol/mol), and Achievement of HbA1c target of < 7% (< 53 mmol/mol). Body weight
loss: defined as (loss of) absolute body weight, Total Body Weight Loss
(%TBWL), Excess BMI loss (%EBL), excess weight loss (%EWL); Quality of life;
SF-36 questionnaire, BAROS (Bariatric Analysis and Reporting Outcome System)
score; Cardiovascular risk factors and 10-year cardiovascular risk estimates
according to the United Kingdom Prospective Diabetes study risk engine;
Microalbuminuria (urinary albumin/creatinin ratio > 2.5 g/mol for men and > 3.5
g/mol for women); surgical complication rate: such as anastomotic leakage,
bleeding, wound infection, trombo-embolic events, internal hernia; vitamin
deficiencies: vitamin D, vitamin B12, folate.
Background summary
The prevalence of Type 2 Diabetes Mellitus (DM2) in the Netherlands is
600.000-800.000 and each year ~70.000 new patients are diagnosed. This
increasing number of patients with DM2 is closely correlated with the obesity
epidemic. In obese patients with DM2 adequate glucoregulation is often
difficult to achieve because of the underlying insulin resistance. Weight loss
is perhaps the most important therapeutical intervention in obese patients with
DM2. Weight loss intervenes in the underlying pathophysiology and restores
insulin sensitivity and sometimes even insulin secretion. Weight reducing
surgery, i.e. bariatric surgery, is the only intervention that leads to
persistent weight loss and it is superior above conventional (non-surgical)
treatment. Meta-analyses also showed spectacular metabolic improvement of
bariatric surgery in obese patients with DM2. In addition, two randomized
controlled trials proved the superiority of RYGB above conventional medical
treatment for treatment of DM2 in morbidly obese patients (BMI > 35 kg/m2).
Remission of DM2 occurred in 75% after RYGB surgery compared to none in
conventional group. Different international committees consider to expand the
indications for bariatric surgery in obese patients with DM2 who don*t meet the
international guidelines for bariatric surgery. The committees underline the
necessary for more researches in moderate obese patients (BMI 30 - 35 kg/m2)
and uncontrolled DM2 with conventional medical therapy. We therefore propose
to study the effectiveness of a RYGB in moderate obese patients (BMI 30 * 35
kg/m2) with DM2.
Study objective
We hypothesize that laparoscopic RYGB surgery is more effective on glycaemic
control than conventional therapy in moderate obese patients with BMI 30 * 35
kg/m2 .
Study design
A single center, non-blinded, randomized controlled trial.
Intervention
The patients will be randomized in the intervention group (RYGB) or the control
group (conventional therapy group).
Study burden and risks
The study will be part of the regular medical care after Gastric Bypass or
conventional diabetes therapy. There will be no extra (invasive) research
moments for participatin patients; only questionnairies.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
1. Informed consent
2. Age 18 * 50 years
3. BMI 30-35 kg/m2
4. Medical history of DM2
a. Metformin + (SU-derivate/DPP4-remmer)
b. Insulin dependent; with or without oral diabetic medication
c. GLP-1 analogue; with or without oral diabetic medication
5. HbA1c > 7.0% and Fasting Plasma Glucose (FPG) > 7.9 mmol/L
Exclusion criteria
1. No diabetes
2. History of bariatric surgery
3. C-peptide <0,27nmol/L
4. Enable to follow medical advises: language barrier, genetic disorders
5. Obesity due to medical disorder (e.g. Cushing syndrome)
6. Contra-indication for RYGB surgery: inflammatory bowel disease (Morbus Crohn / Colitis Ulcera)
7. Renal failure (MDRD < 30)
8. Pregnancy
9. Psychiatric disorder
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47022.091.13 |