NCT06144593 The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes

Trial Parameters

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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 intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.

Eligibility Criteria

Inclusion Criteria: * 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 Criteria: * 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

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