Bariatric Surgery Candidate, Diabetes Mellitus, Obesity, Weight Loss
Conditions
Brief summary
Type 2 diabetes mellitus (T2DM) is a chronic progressive illness affecting a substantial percentage of the general population. While pharmacotherapy remains the mainstay of treatment, around 60% of patients cannot achieve the recommended goals for diabetic control. Weight control is a well-known essential component in normalizing blood glucose level in T2DM. The term metabolic surgery is recently introduced and it is now increasingly accepted as a valid option for obese T2DM patients with poor glycemic control despite optimal medical therapy. While laparoscopic roux-en-Y gastric bypass (RYGBP) is the gold-standard bariatric/metabolic procedure in many countries, it is not widely accepted in Asia. Recently, a novel bypass technique called single loop duodenojejunal bypass with sleeve gastrectomy (SLDJB-SG) has been developed trying to tackle most drawbacks of RYGBP. Realizing there is a knowledge gap in applying the new duodenojejunal bypass procedure to obese T2DM patients, we propose to investigate and compare the efficacy of glycemic control and functional outcomes of SLDJB-SG with conventional RYGBP.
Detailed description
Aim of study: To investigate and compare the safety profile, functional outcomes, efficacy in diabetic control and changes of hormonal profile of laparoscopic single loop duodenojejunal bypass plus sleeve gastrectomy (SLDJB-SG) versus the conventional standard roux-en-Y gastric bypass (RYGBP). Hypothesis: The efficacy of glycemic control and functional outcomes of SLDJB-SG is better than conventional RYGBP, and is a more suitable option for obese Chinese diabetic patients.
Interventions
PROCEDURESleeve gastrectomy + duodeno-jejunal bypass
PROCEDURERoux-Y gastric bypass
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* aged between 20 to 65 years * at least 2 years of T2DM * a BMI between 28 to 42 kg/m2 * a HbA1c level above 7% despite multiple oral medications (\> 2) at higher than or equal to half-maximal dose, or already using insulin injection for more than 6 months * no active cardiovascular diseases, and * a ASA grade II or below * a fasting C-peptide \< 0.6ug/L
Exclusion criteria
* significant anaesthetic risk ASA grade III or above * history of diabetic ketoacidosis * uncontrolled DM with HbA1c \> 12% * malignancy diagnosed within 5 years * chronic renal failure requiring dialysis * previous upper abdominal surgery affecting gastroduodenal configuration * major psychiatric illness including major depression and substance abuse * pregnancy or ongoing breast-feeding * inmates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| % of patient achieve HbA1c<6% | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | during operation | Total blood loss data from operation record |
| Perioperative complications | 30 days | — |
| mortality | 30 days | — |
| operation time | during operation | — |
| Excessive body weight loss (kg) | 6 months & 1 year | — |
| BMI change (kg/m^2) | 6 months & 1 year | — |
| Postoperative hospital stay | during index operation | — |
Countries
China
Contacts
Primary ContactEnders Ng, MD
Backup ContactCandice Lam, BN
Outcome results
None listed