Evidence map›Paper›PMID 27643725›Full record

Trial reportNutrition & diabetes2016

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus.

A Goday, D Bellido, I Sajoux, A B Crujeiras, B Burguera, P P García-Luna, A Oleaga, B Moreno, F F Casanueva

3 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nutrition & diabetes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 130 papers, 20 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
130citing papers in PubMed, 20 pooled it
10.3field-weighted citation impact, top 1% 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.

NCT04801173 nacompletednot on this mapstarted 2021, after this paper: background citation

Effect of Very Low Calorie Ketogenic Diet on Obese and Insulin-resistant Women With Polycystic Ovary Syndrome: a Controlled Randomized Trial

TypeinterventionalSponsorIRCCS Azienda Ospedaliero-Universitaria di BolognaRan2021 to 2021Enrolled30ConditionsPCOS, Obesity, Insulin ResistanceArmsVery low calorie ketogenic diet, Low calorie standard diet
NCT05275608 narecruitingnot on this mapstarted 2022, after this paper: background citation

Effects of Very Low Calorie Ketogenic Diet on Microbiota, Adipose Tissue and Immunitary Regulation: Pilot Study on Patients with Metabolic Syndrome

TypeinterventionalSponsorAzienda Ospedaliero Universitaria Maggiore della CaritaRan2022 to 2025Enrolled40ConditionsDiabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Obesity, Metabolic SyndromeArmsVLCKD diet with replacing meals, Hypocaloric mediterranean Diet
NCT06275347 nacompletednot on this mapstarted 2021, after this paper: background citation

Comparative Study of the Response to Weight Loss and Metabolic Conditions Using Two Non-pharmacological Nutritional Programs

TypeinterventionalSponsorUniversidad VeracruzanaRan2021 to 2023Enrolled88ConditionsObesityArmsLow-fat normoprotein Controlled Ketogenic Diet., Hypocaloric Balanced Diet
3 · Its place in the literature

Who cites it

130 citing papers in PubMed, 20 syntheses or guidelines pooled it, 257 citations in OpenAlex.

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70 more citing papers are in PubMed but not listed here.

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

9 authors at 8 institutions in 1 country.

A GodayDepartment of Endocrinology and Nutrition, Hospital del Mar, Barcelona, Spain.
D BellidoDivision of Endocrinology, Complejo Hospitalario Universitario de Ferrol and Coruña University, Ferrol, Spain.
I SajouxMedical Department, Pronokal Group, Barcelona, Spain.
A B CrujeirasDivision of Endocrinology, Department of Medicine, Complejo Hospitalario Universitario de Santiago (CHUS) and Santiago de Compostela University (USC), Santiago de Compostela, Spain.
B BurgueraEndocrinology and Nutrition Department, Hospital Universitario Son Espases, Mallorca, Spain.
P P García-LunaClinical Nutrition and Morbid Obesity Unit. Hospital Universitario Virgen del Rocio, Sevilla, Spain.
A OleagaEndocrinology Department, Basurto Hospital, Bilbao, Spain.
B MorenoEndocrinology and Nutrition Division, Hospital Universitario Gregorio Marañon, Madrid, Spain.
F F CasanuevaDivision of Endocrinology, Department of Medicine, Complejo Hospitalario Universitario de Santiago (CHUS) and Santiago de Compostela University (USC), Santiago de Compostela, Spain.
Complejo Hospitalario Universitario de Santiago · ESCentro de Investigación Biomédica en Red · ESComplexo Hospitalario Universitario A Coruña · ESHospital de Basurto · ESHospital General Universitario Gregorio Marañón · ESHospital Universitario Son Espases · ESHospital Universitario Virgen del Rocío · ESPronoKal Group (Spain) · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

unlabelledBrackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients.

objectiveEvaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM.

methodsEighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m(-)(2) participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet.

resultsNo significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up.

conclusionsThe interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.

Indexed as

Caloric RestrictionDiet, KetogenicDiet, ReducingAdultAgedBehavior TherapyBlood GlucoseDiabetes Mellitus, Type 2FemaleGlycated HemoglobinHumansLife StyleMaleMiddle AgedProspective StudiesTreatment OutcomeBlood GlucoseGlycated Hemoglobin

Identifiers

PMID27643725
PMCPMC5048014
OpenAlexW2521554955

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.