Liang 2013.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design |
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| Participants |
Inclusion criteria: T2DM diagnosed according to WHO criteria. Other inclusion criteria were: (1) obesity (body mass index [BMI] > 28 kg/m2) in accordance with the WHO Asia‐Pacific classification for obesity; (2) T2DM with hypertension of 5–10 years with hypertension defined as systolic blood pressure (SBP) 140 mmHg and/or diastolic blood pressure (DBP) 90 mmHg as per 1999 WHO/ISH criteria; (3) insulin therapy in combination with oral administration of drugs for 12 months; (4) glycated haemoglobin (HbA1c) > 7%; (5) age: 30–60 years; (6) seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD); (7) C‐peptide level 0.3 mg/L. Exclusion criteria: (1) people without diabetes; (2) type 1 diabetes mellitus, presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD, and gestational diabetes; (3) patients with heart, liver, or renal function impairment; (4) presence of severe infections or cerebrovascular disease; (5) fasting serum insulin was less than one‐third of the normal value; (6) diabetes of more than 10 years duration; (7) age > 60 years or <30 years. Diagnostic criteria: type 2 diabetes requiring insulin and oral drugs for 12 months, hypertension, BMI > 28 kg/m2 |
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| Interventions |
Number of study centres: 1 Treatment before study: insulin and oral diabetes drugs taken for 12 months (an inclusion criterion) Titration period: not applicable Interventions: 1. Usual care (multidisciplinary team; diet, exercise and biochemical goals) 2. Usual care plus exenatide 3. Laparoscopic Roux‐en‐Y gastric bypass |
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| Outcomes | Outcomes reported in abstract of publication: weight loss, comorbidities | |
| Study details |
Run‐in period: none reported Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: research grants from the National Natural Science Foundation of China Publication status: peer reviewed journal |
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| Stated aim for study | Quote: (stated in abstract) "to evaluate the effect of laparoscopic Roux‐en‐Y gastric bypass (RYGB) surgery compared with usual care with and without Exenatide therapy in obese people with type 2 diabetes mellitus (T2DM) and hypertension" Also stated (p. 52): "The primary aim of this trial was the change in cardiac function in patients undergoing RYGB surgery, usual care or GLP‐1 therapy. The secondary aims were to assess changes in metabolic parameters (BMI, HbA1c, HOMA‐IR and lipids) and inflammation (hs‐CRP, TNF‐a, HMW‐adiponectin) after a 12‐month treatment period" |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication "use of a computerized system for generating random numbers" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided |
| Incomplete outcome data (attrition bias) Weight | Unclear risk | Comment: analysis population unclear. Seven patients dropped out after randomisation (usual care = 0, usual care + exenatide = 2, LRYGB = 5) – however stated all patients were followed up; it was not reported why they withdrew, nor at what time they withdrew |
| Incomplete outcome data (attrition bias) Comorbidities | Unclear risk | Comment: as stated above for weight loss |
| Selective reporting (reporting bias) | High risk | Comment: hypoglycaemic episodes stated as measured but no data reported. Considered a key outcome given that a glycaemia‐modifying drug was part of the intervention |
| Other bias | Low risk | Comment: no evidence of other bias |