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

Hvidovre University Hospital

Status: Enrolling

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

Treatments: Other: Dietary macronutrient composition

Study type: Interventional

Funder types: Other

Identifiers

NCT06144593

INTERCARB - H-23043085

Details and patient eligibility

About

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.

Enrollment: 14 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No 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 <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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Intermittent carbohydrate restriction

Experimental group

Description:

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.

Treatment:

Other: Dietary macronutrient composition

Control arm

No Intervention group

Description:

Four weeks of free-living with no dietary restrictions.