Safety and efficacy of intermittent fasting with or without exercise in people living with overweight or obesity and type 2 diabetes-The INTERFAST-3 study design
Sourij C, Müller A, Al-Baghdadi A, Aziz F, Tripolt NJ, Pferschy PN, Andritz E, Kojzar H, Stadlbauer V, Garcia SL, Sourij H
Diabetic medicine : a journal of the British Diabetic Association · 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
- Gobierno
- Austrian Science Fund
- Gobierno
- Austrian Science Fund FWF
Según 2 financiadores declarados y la declaración de financiación del texto completo.
Publicación
- Publicado
- 2026-04-15 · Diabet Med · vol. 43 · número 7 · pág. e70328
- Editorial
- Wiley
- Citado
- 0 citas · más que el 24% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 25 trabajos
- Acceso
- Acceso abierto (revista híbrida) · CC-BY
- Áreas de investigación
- Dietary Effects on Health · Diabetes Management and Research · Diabetes, Cardiovascular Risks, and Lipoproteins
- Palabras clave
- intermittent fasting, intermittent energy restriction, physical activity, type 2 diabetes, obesity, overweight, lifestyle intervention, caloric restriction, weight loss, glycemic control, HbA1c, resting energy expenditure, body composition, gut microbiota, continuous glucose monitoring, non-insulin-treated diabetes
- MeSH
- humans, diabetes mellitus, type 2, obesity, weight loss, blood glucose, body mass index, treatment outcome, combined modality therapy, exercise, exercise therapy, caloric restriction, adult, middle aged, female, male, overweight, glycemic control, glycated hemoglobin, intermittent fasting
11 autores
- Caren Sourij🇦🇹Medical University of Graz
- Alexander Müller🇦🇹Medical University of Graz
- Abdullah Al-Baghdadi🇦🇹Medical University of Graz
- Faisal Aziz🇦🇹Medical University of Graz
- Norbert Joachim Tripolt🇦🇹Medical University of Graz
- Peter N. Pferschy🇦🇹Medical University of Graz
- Eva Andritz🇦🇹Medical University of Graz
- Harald Kojzar🇦🇹Medical University of Graz
- Vanessa Stadlbauer🇦🇹Medical University of Graz
- Sabrina Leal Garcia🇦🇹Medical University of Graz
- Harald Sourij🇦🇹 · autor de correspondenciaMedical University of Graz
Resumen
El texto original del estudio, en el idioma en que se publicó.
Aims
Lifestyle modification, including caloric restriction and exercise, is fundamental in the treatment of people living with overweight and type 2 diabetes mellitus (T2D). The overall aim of lifestyle intervention schemes is to reduce body weight and improve glycaemic control to reduce the future risk of diabetes-associated complications. The aim of this study is to determine whether intermittent energy restriction, exercise or their combination is best suited for reaching these targets in individuals with T2D not treated with insulin.
Methods
This randomized, controlled, monocentric parallel-group trial is designed to investigate participants living with T2D, body mass index >27 kg/m2, HbA1c ≥53 mmol/mol (≥7.0%) and ≤86 mmol/mol (≤10.0%) and without insulin therapy. Participants are equally and randomly allocated to one of four study groups: (1) intermittent energy restriction group, (2) exercise group, (3) combined intermittent energy restriction and exercise group and (4) control group. The intervention phase lasts 12 weeks, followed by a two-year follow-up phase. In addition to assessing body weight and glycaemic parameters, resting energy expenditure (REE) and body composition are measured. An oral glucose tolerance test is carried out at baseline and at the end of the intervention. Additionally, stool samples for microbiome analyses and individual-related outcomes are collected, and all participants are equipped with continuous glucose monitoring (CGM). The primary outcome measure is the change in bodyweight from baseline to day 84.
Trial registration
The study was registered at DRKS (Deutsches Register Klinischer Studien-German Clinical Trial Register DRKS-ID: DRKS00032036)-Date of registration: 11.10.2023.
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