Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol
Retnakaran M, Lessa VL, Kramer CK
PloS one · 1 cita
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
Según la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-03-12 · PLoS One · vol. 21 · número 3 · pág. e0343494
- Editorial
- Public Library of Science
- Citado
- 0 citas · más que el 15% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 32 trabajos
- Acceso
- Acceso abierto (revista) · CC-BY
- Áreas de investigación
- Dietary Effects on Health · Diabetes Treatment and Management · Diabetes Management and Research
- Palabras clave
- time-restricted eating, type 2 diabetes, metabolic health, beta-cell function, insulin resistance, glucose homeostasis, obesity, weight loss, dietary intervention, long-term adherence, disease-modifying therapy
- MeSH
- humans, diabetes mellitus, type 2, insulin resistance, obesity, female, male, overweight, insulin-secreting cells, intermittent fasting
3 autores
- Matthew Retnakaran🇨🇦Mount Sinai Hospital
- Vittória Lovato Lessa🇨🇦🇧🇷Mount Sinai Hospital; Universidade Vila Velha
- Caroline Kaercher Kramer🇨🇦 · autor de correspondenciaMount Sinai Hospital; University of Toronto; Lunenfeld-Tanenbaum Research Institute
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Recent findings have suggested that implementing the emerging weight-loss strategy of time-restricted eating (TRE) for 6 weeks can have beneficial effects on the key pathophysiologic determinants of type 2 diabetes (T2DM) - namely, pancreatic beta-cell function and insulin resistance. Given the chronic nature of T2DM and the general challenge of long-term adherence to dietary interventions, a critical question is the durability of such effects. Specifically, we seek to determine whether TRE can improve the metabolic health of patients with T2DM over 1 year.
Methods
In this open-label, parallel-arm, randomized controlled trial, individuals with overweight/obesity and T2DM of <10 years duration will be randomized to either standard lifestyle recommendations or TRE. The TRE protocol will consist of 18 hours of fasting and a 6 hour window of eating (between 2-8 PM) each day. The duration of the intervention will be 52-weeks and participants will undergo metabolic characterization at baseline, 12-24-, 36- and 52-weeks. The primary outcome of pancreatic beta-cell function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2). Additional metabolic measures will include insulin resistance and glucose homeostasis.
Discussion
TRE may represent an adjunct therapeutic approach for improving the metabolic profile of overweight/obese individuals with T2DM while also providing the capacity for modification of its underlying pathophysiology. This evaluation of the durability of the metabolic effects of TRE on beta-cell function and insulin resistance could thus identify a role for this dietary strategy as a disease-modifying intervention early in the course of T2DM.
Trial registration
clinicaltrials.gov NCT07272460.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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