About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Dietary macronutrient composition
Other interventionIntermittent carbohydrate restriction
Treatment groups
Trial outcomes
Primary outcomes
24-hour average sensor glucose
A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period.
Secondary outcomes
Liver triacylglycerol content
Liver TG content will be measured by 1H-Magnetic Resonance Spectroscopy (MRS) on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).
Fasting plasma concentrations of triacylglycerols
Fasting plasma concentrations of triacylglycerols measured on the day before and the day after the 4-week dietary intervention (i.e. day 0 and day 30) and on the day before and the day after the 4-week control period (i.e. day 0 and day 30).
Other outcomes
Explorative outcomes - Questionnaires on quality of life
Participants will complete the questionnaires 'Problem Areas In Diabetes' \& 'World Health Organisation-Five Well-Being Index'.
Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy
A semi-structured evaluation interview to assess social context, eating practices, compliance to, and feasibility and acceptability of the intermittent carbohydrate restriction regime will be carried out.
Sponsors and contacts
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Hvidovre University Hospital
Lead sponsor
University of Copenhagen
Collaborator
Danish Research Centre for Magnetic Resonance
Collaborator