Investigating the effects of intermittent carbohydrate restriction on glucose levels in type 2 diabetes
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
This study is testing if switching between two days of regular eating and two days of cutting back on carbs can help people with type 2 diabetes manage their blood sugar levels better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT06144593 on ClinicalTrials.gov |
What this trial studies
This randomized cross-over intervention examines how alternating between two days of normal dietary intake and two days of carbohydrate restriction affects glucose levels over a four-week period in individuals with type 2 diabetes. Participants will undergo a control period with normal dietary intake to compare results. The study focuses on dietary macronutrient composition and its metabolic impact on glucose regulation. It aims to provide insights into dietary strategies for managing type 2 diabetes effectively.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 35-75 with a BMI greater than 27 kg/m2 and stable type 2 diabetes management.
Not a fit: Patients with severe dietary restrictions, recent significant weight loss, or those on certain diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved glucose control and management strategies for individuals with type 2 diabetes.
How similar studies have performed: While intermittent dietary approaches have shown promise in other studies, this specific method of carbohydrate restriction is relatively novel and untested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Hvidovre
- Department of Endocrinology, Hvidovre Hospital — Hvidovre, Denmark (Recruiting)
Study contacts
- Study coordinator: Amanda Schaufuss, MSc
- Email: amanda.schaufuss@regionh.dk
- Phone: +4530270261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.