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

NCT06144593 | Recruiting

• 1 other identifier: INTERCARB - H-23043085
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Liver triacylglycerol content

  day 30 adjusted for baseline

• Fasting plasma concentrations of triacylglycerols

  day 30 adjusted for baseline

Other Outcomes (2)

• Explorative outcomes - Questionnaires on quality of life

  day 30

• Explorative outcomes - Qualitative evaluation to assess feasibility of the dietary strategy

  day 30

Study Arms (2)

Intermittent carbohydrate restriction

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Four weeks of free-living with no dietary restrictions.

Interventions

Dietary macronutrient composition OTHER

Intermittent carbohydrate restriction

Intermittent carbohydrate restriction

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hvidovre University Hospital: lead
• University of Copenhagen: collaborator
• Danish Research Centre for Magnetic Resonance: collaborator

Study Sites (1)

Department of Endocrinology, Hvidovre Hospital

Hvidovre, 2650, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism

Central Study Contacts

Amanda Schaufuss, MSc

CONTACT

+4530270261; amanda.schaufuss@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: Dietary intervention

Study Record Dates

• First Submitted: September 29, 2023
• First Posted: November 22, 2023
• Study Start: January 3, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 6, 2024

Record last verified: 2024-06

Locations

DK (1)