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Intermittent fasting for weight loss in people with type 2 diabetes

Early Time Restricted Eating with Caloric Restriction as Weight Loss Strategy Based on the Mediterranean Diet for Adults with Type 2 Diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20271
Enrollment
172
Registered
2021-09-28
Start date
2022-10-03
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

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 1

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Type 2 diabetes • BMI 27 kg/m2 of hoger • 18-75 jaar • In bezit van een smartphone

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Between-group difference in HbA1c (mmol/mol) from baseline to one year. HbA1c will be measured with routine clinical lab procedures

Secondary

MeasureTime frame
• 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

Contacts

Public ContactCarmen Dietvorst

Erasmus MC

c.dietvorst@erasmusmc.nl(010)7033055

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)