Trial reportBMJ open diabetes research & care2020
Low-energy total diet replacement intervention in patients with type 2 diabetes mellitus and obesity treated with insulin: a randomized trial.
Trial report in BMJ open diabetes research & care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 38 citations in OpenAlex.
- A DiRECT approach to weight loss in a culturally diverse, low-income population: Pilot randomised controlled trial and meta-analysis of similar interventions.Diabetes, obesity & metabolism · 2025Pooled it
- Meal replacements on obesity and leptin: a systematic review and meta-analysis.Reviews in endocrine & metabolic disorders · 2025Pooled it
- Pooled it
- Pooled it
- Restricting carbohydrates and calories in the treatment of type 2 diabetes: a systematic review of the effectiveness of 'low-carbohydrate' interventions with differing energy levels.Journal of nutritional sciencePooled it
- A high-protein total diet replacement alters the regulation of food intake and energy homeostasis in healthy, normal-weight adults.European journal of nutrition · 2022Trial
- Trial
- Low Energy Diets for Obesity and CKD (SLOW-CKD Randomized Feasibility Study).Kidney international reports · 2025Article
- Effectiveness of Calorie Restriction for Weight Loss in Type 2 Diabetes Mellitus: A Systematic Review.Cureus · 2025Review
- The effect of meal replacements therapy on blood pressure and C-reactive protein: a systematic review and meta-analysis of randomized controlled trials.Clinical hypertension · 2025Review
- Chinese Guidelines for Medical Nutrition Therapy for Patients with Diabetes (2022 Edition).Asia Pacific journal of clinical nutrition · 2024Article
- A comparison of virtual and in person delivery of a full meal replacement program for obesity.Obesity science & practice · 2024Article
- Article
- UK dietitians' attitudes and experiences of formula very low- and low-energy diets in clinical practice.Clinical obesity · 2022Article
- Standardised Outcome Reporting for the Nutrition Management of Complex Chronic Disease: A Rapid Review.Nutrients · 2021Review
- Factors associated with engagement and adherence to a low-energy diet to promote 10% weight loss in patients with clinically significant non-alcoholic fatty liver disease.BMJ open gastroenterology · 2021Article
- A high-protein total diet replacement increases energy expenditure and leads to negative fat balance in healthy, normal-weight adults.The American journal of clinical nutrition · 2021Article
- COVID-19: Obesity, deprivation and death.Journal of global health · 2020Review
- Diet and exercise in the prevention and treatment of type 2 diabetes mellitus.Nature reviews. Endocrinology · 2020 · on this mapReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 4 countries.
Funding
Abstract
objectivesThe management of patients with long-standing type 2 diabetes and obesity receiving insulin therapy (IT) is a substantial clinical challenge. Our objective was to examine the effect of a low-energy total diet replacement (TDR) intervention versus standardized dietetic care in patients with long-standing type 2 diabetes and obesity receiving IT. RESEARCH DESIGN AND
methodsIn a prospective randomized controlled trial, 90 participants with type 2 diabetes and obesity receiving IT were assigned to either a low-energy TDR (intervention) or standardized dietetic care (control) in an outpatient setting. The primary outcome was weight loss at 12 months with secondary outcomes including glycemic control, insulin burden and quality of life (QoL).
resultsMean weight loss at 12 months was 9.8 kg (SD 4.9) in the intervention and 5.6 kg (SD 6.1) in the control group (adjusted mean difference -4.3 kg, 95% CI -6.3 to 2.3, p<0.001). IT was discontinued in 39.4% of the intervention group compared with 5.6% of the control group among completers. Insulin requirements fell by 47.3 units (SD 36.4) in the intervention compared with 33.3 units (SD 52.9) in the control (-18.6 units, 95% CI -29.2 to -7.9, p=0.001). Glycated Hemoglobin (HbA1c) fell significantly in the intervention group (4.7 mmol/mol; p=0.02). QoL improved in the intervention group of 11.1 points (SD 21.8) compared with 0.71 points (SD 19.4) in the control (8.6 points, 95% CI 2.0 to 15.2, p=0.01).
conclusionsPatients with advanced type 2 diabetes and obesity receiving IT achieved greater weight loss using a TDR intervention while also reducing or stopping IT and improving glycemic control and QoL. The TDR approach is a safe treatment option in this challenging patient group but requires maintenance support for long-term success. TRIAL REGISTRATION NUMBER: ISRCTN21335883.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.