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

Sponsor

Hvidovre University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06144593

Collaborator

University of Copenhagen (Other), Danish Research Centre for Magnetic Resonance (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Overweight and Obesity Non-Alcoholic Fatty Liver Disease Metabolic Syndrome	Other: Dietary macronutrient composition	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Dietary interventionDietary intervention

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Dietary macronutrient composition Intermittent carbohydrate restriction
No Intervention: Control arm Four weeks of free-living with no dietary restrictions.

Arm

Intervention/Treatment

Experimental: 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.

Other: Dietary macronutrient composition

Intermittent carbohydrate restriction

No Intervention: Control arm

Four weeks of free-living with no dietary restrictions.

Outcome Measures

Primary Outcome Measures

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

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 <90 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)