Evidence mapPaperPMID 28132008Full record

Trial reportBMJ open2017

Compensatory changes in energy balance during dapagliflozin treatment in type 2 diabetes mellitus: a randomised double-blind, placebo-controlled, cross-over trial (ENERGIZE)-study protocol.

Surya Panicker Rajeev, Victoria S Sprung, Carl Roberts, Jo A Harrold, Jason C G Halford, Andrej Stancak, Emma J Boyland, Graham J Kemp, Daniel J Cuthbertson, John P H Wilding

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 17% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. SGLT2 Inhibitors and the Clinical Implications of Associated Weight Loss in Type 2 Diabetes: A Narrative Review.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2021
    Article
  6. Proglucagon-Derived Peptides as Therapeutics.Frontiers in endocrinology · 2021
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Surya Panicker RajeevInstitute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
Victoria S SprungDiabetes and Endocrinology Research Group, Clinical Sciences Centre, Aintree University Hospital NHS Foundation Trust, Liverpool, UK.
Carl RobertsDepartment of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Jo A HarroldDepartment of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Jason C G HalfordDepartment of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Andrej StancakDepartment of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Emma J BoylandDepartment of Psychological Sciences, Institute of Psychology, Health and Society, University of Liverpool, Liverpool, UK.
Graham J KempDepartment of Musculoskeletal Biology II, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
Daniel J CuthbertsonDiabetes and Endocrinology Research Group, Clinical Sciences Centre, Aintree University Hospital NHS Foundation Trust, Liverpool, UK.
John P H WildingInstitute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.
University of Liverpool · GBAintree University Hospitals NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSodium glucose cotransporter 2 (SGLT2) inhibitors are effective blood-glucose-lowering medications with beneficial effects on body weight in patients with type 2 diabetes mellitus (T2DM). However, observed weight loss is less than that predicted from quantified glycosuria, suggesting a compensatory increase in energy intake or a decrease in energy expenditure. Studies using dual-energy X-ray absorptiometry (DEXA) have suggested most body weight change is due to loss of adipose tissue, but organ-specific changes in fat content (eg, liver, skeletal muscle) have not been determined. In this randomised, double-blind, placebo-controlled crossover study, we aim to study the compensatory changes in energy intake, eating behaviour and energy expenditure accompanying use of the SGLT2 inhibitor, dapagliflozin. Additionally, we aim to quantify changes in fat distribution using MRI, in liver fat using proton magnetic resonance spectroscopy ( METHODS AND ANALYSIS: This outpatient study will evaluate the effect of dapagliflozin (10 mg), compared with placebo, on food intake and energy expenditure at 7 days and 12 weeks. 52 patients with T2DM will be randomised to dapagliflozin or placebo for short-term and long-term trial interventions in a within participants, crossover design. The primary outcome is the difference in energy intake during a test meal between dapagliflozin and placebo. Intake data are collected automatically using a customised programme operating a universal eating monitor (UEM). Secondary outcomes include (1) measures of appetite regulation including rate of eating, satiety quotient, appetite ratings (between and within meals), changes in CNS responses to food images measured using BOLD-fMRI, (2) measures of energy expenditure and (3) changes in body composition including changes in liver fat and abdominal visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT). ETHICAL APPROVAL: This study has been approved by the North West Liverpool Central Research Ethics Committee (14/NW/0340) and is conducted in accordance with the Declaration of Helsinki and the Good Clinical Practice (GCP). TRIAL REGISTRATION NUMBER: ISRCTN14818531. EUDRACT number 2013-004264-60.

Indexed as

Energy MetabolismAdipose TissueBenzhydryl CompoundsBody CompositionBody Fat DistributionBrainCalorimetry, IndirectCross-Over StudiesCuesDiabetes Mellitus, Type 2Double-Blind MethodEatingFeeding BehaviorFoodFunctional NeuroimagingGlucosidesBenzhydryl CompoundsdapagliflozinGlucosidesHypoglycemic Agents

Identifiers

PMID28132008
PMCPMC5278268
OpenAlexW2580331548

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.