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

Diabetes Mellitus, Type 2 Clinical Trial

— INTERCARB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144593
• Other study ID #: INTERCARB - H-23043085
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2024
• Source: Hvidovre University Hospital
• Contact: Amanda Schaufuss, MSc
• Phone: +4530270261
• Email: amanda.schaufuss[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Dietary macronutrient composition
Intermittent carbohydrate restriction

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Hvidovre Hospital	Hvidovre

Sponsors (3)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Danish Research Centre for Magnetic Resonance, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explorative outcomes - Questionnaires on quality of life	Participants will complete the questionnaires 'Problem Areas In Diabetes' & 'World Health Organisation-Five Well-Being Index'.	day 30
Other	Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy	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.	day 30
Primary	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.	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	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).	day 30 adjusted for baseline
Secondary	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).	day 30 adjusted for baseline