To evaluate the effect and costs of a RYGB vs conventional therapy as glucoregulatory treatment for DM2 patients with a BMI>35 kg/m2 and HbA1c >7% despite 2 blood glucose lowering agents (not being insulin).
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference between the intervention groups in HbA1c, percentage with Hba1c <7%,
percentage with diabetes remission (FPG <7.1 mmol/L, HbA1c <6.5% without
medication)
cost-utility analysis from a social perspective
Secondary outcome
quality of life, body weight, cardiovascular risk factors and 10-year
cardiovascular risk.
Background summary
600.000-800.000 people have type 2 diabetes (DM2) in the Netherlands, with
70.000 new patients yearly. Most DM2 patients are obese. DM2 is a chronic
progressive disease. Presently,no pharmacological intervention integrally
treats the underlying pathophysiological process. Weight loss is the most
important therapeutical measure, but the effect of diet, exercise and drugs is
marginal and short-lived. Bariatric surgery, especially Roux-en-Y gastric
bypass (RYGB), effectively reduces glucose levels and bodyweight in obese DM2
patients. Dutch treatment guidelines do not include specific recommendations
for obese DM2 patients. Most patients are treated with multiple (expensive)
drugs while the HbA1c target of <7% is often not achieved and the disease
progresses. A RYGB might be a more effective alternative. Initial costs will be
higher than pharmacotherapy, but in the long term savings are expected due to
greater effectiveness. Class I evidence endorsing the (cost-)effectiveness of a
RYGB versus conventional treatment for obese DM2 patients is lacking.
Study objective
To evaluate the effect and costs of a RYGB vs conventional therapy as
glucoregulatory treatment for DM2 patients with a BMI>35 kg/m2 and HbA1c >7%
despite 2 blood glucose lowering agents (not being insulin).
Study design
prospective, randomized, controlled, multicenter trial.
Intervention
RYGB surgery versus conventional therapy for DM2 (NHG standaard) and obesity
(CBO guideline)
Study burden and risks
We compare the costs and effectiveness of 2 registred interventions for the
treatment of obese DM 2 patients. The treating physician is the one primarily
responsible for the treatment of his/her patient.
The study only measures the outcomes of these 2 interventions. For the study
patients have to visit the research phycisian 8 times over a period of 3 years.
Given the importance of the oucome of this investigation this burden is minimal
en defiable.
Albinusdreef 2
2333 ZA Leiden
NL
Albinusdreef 2
2333 ZA Leiden
NL
Listed location countries
Age
Inclusion criteria
• Informed consent
• Age 18-60 years
• DM2
. fasting c-peptide > 0.8 ng/ml
• HbA1c > 7.0 % despite diet/lifestyle advises and 2 glucose-lowering drugs with the exception of insulin
• BMI> 35 kg/m2 and <45 kg/m2
• Has attempted to lose weight without (lasting) succes
Exclusion criteria
• Use of insulin
• Substance abuse/dependence
• Mentally instable/psychiatric disorder (according to evaluation psychologist)
• Some eating disorders
. no diabetes type 2, fasting c-peptide < 0.8 ng/ml
• Physical condition not good enough to sustain operation: IFSO and ASA criteria
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 | NL33979.058.10 |