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

Not Applicable

Recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Overweight and Obesity; Metabolic Syndrome
• Interventions: Other: Dietary macronutrient composition

• Registration Number: NCT06144593
• Lead Sponsor: Hvidovre University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-29
• Study First Submitted QC: 2023-11-16
• Study First Posted: 2023-11-22
• Study Start: 2024-01-03
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intermittent carbohydrate restriction	Dietary macronutrient composition	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Department of Endocrinology, Hvidovre Hospital; 🇩🇰 Hvidovre, Denmark