Status:
RECRUITING
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
University of Copenhagen
Danish Research Centre for Magnetic Resonance
Conditions:
Diabetes Mellitus, Type 2
Overweight and Obesity
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary int...
Eligibility Criteria
Inclusion
- Men or women
- 35-75 years old
- BMI \>27 kg/m2
- Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \>48 mmol/mol if no glucose lowering therapy
Exclusion
- Anemia (hemoglobin \<8 mmol/L for men and \<7 mmol/L for women)
- TSH outside reference range
- Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
- Treatment with systemic corticosteroids
- HbA1c \>70 mmol/mol
- eGFR \<60 ml/min/1.73 m2
- Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
- Food allergies (including lactose and gluten intolerance)
- Vegetarian/vegan diet or following of specific dietary plans
- Alcohol consumptions \>84/168 g/week (women/men)
- Strenuous activity level \> 120 minutes per week
- Weight loss (\>5 kg) within the last three months or previous bariatric surgery
- High risk of fibrosis of the liver (estimated by FIB4 score \> 3.25)
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06144593
Start Date
January 3 2024
End Date
September 1 2025
Last Update
June 6 2024
Active Locations (1)
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1
Department of Endocrinology, Hvidovre Hospital
Hvidovre, Denmark, 2650