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

Hvidovre University Hospital14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2 Overweight and Obesity Non-Alcoholic Fatty Liver Disease Metabolic Syndrome

Interventions

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

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.

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

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

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).