The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- 24-hour average sensor glucose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Intermittent carbohydrate restriction
Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet.
Intervention: Dietary macronutrient composition (Other)
Control arm
Four weeks of free-living with no dietary restrictions.
Outcomes
Primary Outcomes
24-hour average sensor glucose
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).
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(day 30 adjusted for baseline)
- Fasting plasma concentrations of triacylglycerols(day 30 adjusted for baseline)
Investigators
Kirstine Nyvold Bojsen-Moeller
MD, PhD, Associate Professor
Hvidovre University Hospital