Intermittent fasting for weight loss in people with type 2 diabetes
Not Applicable
Recruiting
- Conditions
- <p>Type 2 Diabetes</p>10018424
- Registration Number
- NL-OMON20271
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 172
Inclusion Criteria
• Type 2 diabetes
• BMI 27 kg/m2 of hoger
• 18-75 jaar
• In bezit van een smartphone
Exclusion Criteria
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Between-group difference in HbA1c (mmol/mol) from baseline to one year. HbA1c will be measured with routine clinical lab procedures</p>
- Secondary Outcome Measures
Name Time Method <p>• Body composition • Cardiovascular risk factors • Resting Energy Expenditure • Quality of life • Demographic variables, drug use, smoking and drinking habits, exercise and (diabetes) medication use • Food intake, adherence to the diet interventions and compliance to the time restriction • Patient satisfaction • Chronotype score • Sleep quality • Chrononutrition score • Attrition • Satisfaction and feedback of provided lifestyle book • Process evaluation</p>