Diabetes Mellitus, Type 2, Metabolic Syndrome, Non-Alcoholic Fatty Liver Disease, Overweight and Obesity
Conditions
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.
Interventions
OTHERDietary macronutrient composition
Intermittent carbohydrate restriction
Sponsors
University of Copenhagen
Danish Research Centre for Magnetic Resonance
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention model description
Dietary intervention
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24-hour average sensor glucose | 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). | A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver triacylglycerol content | day 30 adjusted for baseline | 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 | day 30 adjusted for baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Explorative outcomes - Questionnaires on quality of life | day 30 | 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 | day 30 | 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. |
Countries
Denmark
Contacts
Primary ContactAmanda Schaufuss, MSc
Outcome results
None listed