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Ensayo controlado aleatorizado2026Acceso abierto

The Effect of Integrated Lifestyle Intervention Incorporating Calorie-Carbohydrate Restriction With or Without Time-Restricted Feeding for Remission of Type 2 Diabetes (DIREM): A Single Blind Randomised Controlled Trial

Badrooj N, Esteghamati A, Djafarian K, Yekaninejad MS, Mohammadpour S, Dankoob V, Reyhan SK, Abbaszade M, Emamgholipour S, Shab-Bidar S

Endocrinology, diabetes & metabolism · 0 citas

Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Marcadores de salud y funcionamiento

Quién lo pagó

Financiación
Financiación independiente
Universidad u hospital
Tehran University of Medical Sciences and Health Services

Según 1 financiador declarado y la declaración de financiación del texto completo.

Publicación

Publicado
2026-04-11 · Endocrinol Diabetes Metab · vol. 9 · número 3 · pág. e70209
Editorial
Bioscientifica
Citado
2 citas · más que el 97% de estudios similares · 8.1× el promedio de su campo
Impacto
Entre el 10 % más citado de su campo
Referencias
27 trabajos
Acceso
Acceso abierto (revista) · CC-BY
Áreas de investigación
Dietary Effects on Health · Diabetes Management and Research · Diabetes Treatment and Management
Palabras clave
type 2 diabetes remission, intermittent fasting, time-restricted feeding, lifestyle intervention, glycemic control, physical activity, behavioral interventions
MeSH
humans, diabetes mellitus, type 2, blood glucose, caloric restriction, remission induction, fasting, single-blind method, life style, aged, middle aged, female, male, diet, carbohydrate-restricted, intermittent fasting

10 autores

  • Negin Badrooj🇮🇷Tehran University of Medical Sciences
  • Alireza Esteghamati🇮🇷 · autor de correspondenciaEndocrine and Metabolism Research Center; Tehran University of Medical Sciences
  • Kurosh Djafarian🇮🇷Tehran University of Medical Sciences
  • Mir Saeed Yekaninejad🇮🇷Tehran University of Medical Sciences
  • Saba Mohammadpour🇮🇷Shahid Beheshti University; Shahid Beheshti University of Medical Sciences
  • Vida Dankoob🇮🇷Tehran University of Medical Sciences
  • Sahar Karimpour Reyhan🇮🇷Endocrine and Metabolism Research Center; Tehran University of Medical Sciences
  • Mahsa Abbaszadeh🇮🇷Endocrine and Metabolism Research Center; Tehran University of Medical Sciences
  • Sara Emamgholipour🇮🇷Tehran University of Medical Sciences
  • Sakineh Shab‐Bidar🇮🇷🇬🇧 · autor de correspondenciaTehran University of Medical Sciences; University of Glasgow

Resumen

El texto original del estudio, en el idioma en que se publicó.

Aims

We conducted the diet and diabetes remission (DIREM) study to assess whether an integrated lifestyle intervention would lead to achieving remission in type 2 diabetes.

Materials and methods

Patients with type 2 diabetes were randomly assigned to calorie-carbohydrate restriction (CCR) group, intermittent fasting with calorie-carbohydrate restriction (IFCCR), or usual care group (control). The total study duration was 6 months, consisting of two phases: a 12-week integrated lifestyle intervention (ILI) phase, followed by a 12-week maintenance and structured monitoring (MSM) phase. The intervention was presented in the form of a structured behavioural model and also emphasised physical activity.

Results

One hundred and twenty participants were randomly assigned to the study. Diabetes remission occurred in 9 (22.5%) of 40 participants in the CCR group (OR (CCR vs. Control) = 11.7, 95% CI: 1.4-98.3; p = 0.024), 12 (30.0%) of 40 participants in the IFCCR group (OR (IFCCR vs. Control) = 18.1, 95% CI: 2.2-151.0; p = 0.007) and 1 (2.5%) of 40 participants in the control group. The odds of remission were higher in the IFCCR group compared to the CCR group, but it was not significant (OR (IFCCR vs. CCR) = 1.5, 95% CI: 0.6-4.3; p = 0.4).

Conclusions

Both calorie-carbohydrate restriction alone and in combination with intermittent fasting significantly improved glycemic control and induced diabetes remission compared with the control group. No significant difference was found between the two interventions. Larger long-term studies are needed to confirm these findings.

Trial registration

This trial was registered in the Iranian Registry of Clinical Trials (IRCT), IRCT20240418061519N1 (https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT20240418061519N1).

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).

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