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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorHvidovre University Hospital

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Dietary macronutrient composition

    Other intervention

    Intermittent carbohydrate restriction

Treatment groups

14 Participants
are divided into 2 treatment groups
Group A: Intermittent carbohydrate restrictionExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).

Secondary outcomes

1

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).

Time frame
day 30 adjusted for baseline
2

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).

Time frame
day 30 adjusted for baseline

Other outcomes

1

Explorative outcomes - Questionnaires on quality of life

Participants will complete the questionnaires 'Problem Areas In Diabetes' \& 'World Health Organisation-Five Well-Being Index'.

Time frame
day 30
2

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.

Time frame
day 30

Sponsors and contacts

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Hvidovre University Hospital

Lead sponsor

University of Copenhagen

Collaborator

Danish Research Centre for Magnetic Resonance

Collaborator