Mingrone 2012.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: 1:1:1 Superiority design |
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| Participants |
Inclusion criteria: age 30‐60 years, BMI ≥35, type 2 diabetes for at least 5 years, glycated haemoglobin ≥7.0%, ability to understand and comply with study protocol. Exclusion criteria: type 1 diabetes, diabetes secondary to specific disease or glucocorticoid therapy, previous bariatric surgery, pregnancy, other medical conditions requiring short‐term hospitalisation, severe diabetes complications, other severe medical conditions, geographical inaccessibility. Diagnostic criteria: BMI ≥ 35 with type 2 diabetes. |
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| Interventions |
Number of study centres: 1 Treatment before study: none Titration period: n/a Interventions: 1. Gastric bypass (plus daily nutritional supplementation) 2. Medical therapy (treated by a multidisciplinary team including a diabetologist, dietitian and nurse, visits at baseline, 1, 3, 6,9,12 and 24 months. Oral hypoglycaemic agents and insulin doses optimised on an individual basis to reach a glycated haemoglobin level <7%. Programs for diet and lifestyle modification, including reduced overall energy and fat intake (details provided) and increased physical exercise). |
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| Outcomes | Outcomes reported in abstract of publication: comorbidities | |
| Study details |
Run‐in period: not reported Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: non‐commercial: supported by the Catholic University of Rome Publication status: peer reviewed journal |
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| Stated aim for study | Quote: "comparing the efficacy of two types of bariatric surgery (gastric bypass and biliopancreatic diversion) with conventional medical therapy in severely obese patients with Type 2 diabetes" (Mingrone 2012, p. 1578) | |
| Notes | BMI: body mass index; GB: gastric bypass; n/a: not applicable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "use of a computerised system for generating random numbers" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no details reported |
| Incomplete outcome data (attrition bias) Weight | Low risk | Comment: missing numbers were small and appeared to be balanced however unclear whether dropouts are related to outcome |
| Incomplete outcome data (attrition bias) Comorbidities | Low risk | Comment: missing numbers were small and appeared to be balanced however unclear whether dropouts are related to outcome |
| Selective reporting (reporting bias) | High risk | Comment: the study protocol is available. The primary outcome of diabetes remission has not been reported in the way it was pre‐specified. The protocol states that diabetes remission would be assessed in terms of both full and partial remission. In the paper, only “diabetes remission” is reported (unclear if this is full, partial or a composite of both) |
| Other bias | Low risk | Comment: no evidence of other bias |