Early Time Restricted Eating with Caloric Restriction as Weight Loss Strategy Based on the Mediterranean Diet for Adults with Type 2-Diabetes and/or overweight: a Randomized Controlled Trial.

Recruiting

• Conditions: overgewicht; Diabetes Mellitus Type 2; Non-insulin dependent diabetes; 10018424

• Registration Number: NL-OMON54132
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 222

Inclusion Criteria

• Type 2 Diabetes (main cohort)
• Body Mass Index greater than or equal to 27 kg/m2
• 18-75
• Owns a smart phone

Exclusion Criteria

• Insufficient command of the Dutch language
• Pregnancy or lactation during the trial
• Severe psychiatric disorders , use of antipsychotic drugs
• Serious heart conditions such as: significant heart arrhythmia , unstable
angina pectoris, decompensated congestive heart failure
• Organ failure
• Untreated hypothyroidism
• End-stage renal failure
• Carcinomas
• Transplants, myocardial infarct, cerebrovascular accident, or any large scale
surgery within the last 3 months
• Corticosteroid induced diabetes (in patients still using corticosteroids)
• Start with GLP-1 agonists within the last 3 months

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<br /><br>will be measured with routine clinical lab procedures.<br /><br>For the (pilot) subpopulation, body weight (kg, Seca 888 compact digital flat<br /><br>scale) form baseline to one year will be the primary outcome. </p><br>