RecruitingNot ApplicableNCT06144593

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

Sponsor

Hvidovre University Hospital

Enrollment

14 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Metabolic Syndrome Non-Alcoholic Fatty Liver Disease Diabetes Mellitus, Type 2 Overweight and Obesity

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

Min Age: 35 YearsMax Age: 75 Years

Inclusion Criteria4

Men or women
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 Criteria13

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)