Primary Objective: 1. What is the difference in effectiveness of Early Time-restricted Eating (eTRE) in glycaemic regulation when compared to isocaloric continues caloric restriction (CCR) after one year in overweight adults with type 2 diabetes?…
ID
Bron
Verkorte titel
Aandoening
- Glucosemetabolismestoornissen (incl. diabetes mellitus)
Aandoening
Type 2 Diabetes
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Voedingsstoffen/Voedingsmiddelen
Uitkomstmaten
Primaire uitkomstmaten
Between-group difference in HbA1c (mmol/mol) from baseline to one year. HbA1c will be measured with routine clinical lab procedures
Achtergrond van het onderzoek
Type 2 diabetes prevalence is steadily increasing . Risks are increased in those with overweight or obesity. Weight loss reduces cardiovascular risk and may even lead to remission of diabetes. There is no consensus yet on the most effective weight loss strategy for T2D. Early time restricted eating (eTRE), a form of intermittent fasting, has shown great potential in improving glycaemic regulation in patients with prediabetes. However, eTRE has not been studied in people with T2D and obesity.
Doel van het onderzoek
Primary Objective: 1. What is the difference in effectiveness of Early Time-restricted Eating (eTRE) in glycaemic regulation when compared to isocaloric continues caloric restriction (CCR) after one year in overweight adults with type 2 diabetes? Secondary Objective(s): 2. What is the difference in weight loss, body composition, cardiovascular risk factors and diabetic medication usage between a CCR and eTRE after one year in overweight adults with type 2 diabetes? 3. What is the difference in quality of life, treatment satisfaction, compliance, and adherence between the two diet interventions? 4. Is there an association between patient characteristics and the effectivity of the two diet interventions?
Onderzoeksopzet
Baseline, 3 months, 6 months and 12 months
Onderzoeksproduct en/of interventie
Control group: group treatment with a carbohydrate restricted Mediterranean diet Intervention group: group treatment with a carbohydrate restricted Mediterranean diet and an eating window limited to 10 hours per day (eTRE)
Algemeen / deelnemers
Carmen Dietvorst
Dr. Molewaterplein 40
3015 GD
Rotterdam
Nederland
(010)7033055
c.dietvorst@erasmusmc.nl
Wetenschappers
Carmen Dietvorst
Dr. Molewaterplein 40
3015 GD
Rotterdam
Nederland
(010)7033055
c.dietvorst@erasmusmc.nl
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Type 2 diabetes
• BMI 27 kg/m2 of hoger
• 18-75 jaar
• In bezit van een smartphone
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Beheerst de Nederlandse taal onvoldoende
• Zwangerschap of lacteren tijdens de studie
• Ernstige psychische aandoeningen, gebruik van antipsychotica
• Ernstige hartaandoeningen zoals: significante hartritmestoornissen, onstabiele angina pectoris,gedecompenseerd congestief hartfalen
• Orgaanfalen
• Onbehandelde hypothyreoïdie
• Eindstadium nierfalen
• Carcinomen
• Transplantaties, myocardinfarct, cerebrovasculair accident of elke grootschalige operatie in de afgelopen 3maanden
• Door corticosteroïden geïnduceerde diabetes (bij patiënten die nog steeds corticosteroïden gebruiken)
• Start met GLP-1 agonisten in de laatste 3 maanden
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9756 |
| CCMO | NL78344.078.21 |
| OMON | NL-OMON54132 |