Clinical trial NCT06144593: The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Official title: The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Overweight and Obesity
Non-Alcoholic Fatty Liver Disease
Metabolic Syndrome
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Danish Research Centre for Magnetic Resonance
First posted: 2023-11-22
Enrollment: 14
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dietary intervention
Primary purpose: OTHER

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 (estimated by FIB4 score \> 3.25)

Primary outcomes:
measure: 24-hour average sensor glucose
timeFrame: 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:
measure: Liver triacylglycerol content
timeFrame: day 30 adjusted for baseline
measure: Fasting plasma concentrations of triacylglycerols
timeFrame: day 30 adjusted for baseline
Other outcomes:
measure: Explorative outcomes - Questionnaires on quality of life
timeFrame: day 30
measure: Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy
timeFrame: day 30
Locations:
city: Hvidovre
country: Denmark
facility: Department of Endocrinology, Hvidovre Hospital
Study officials:
References: