Low-carbohydrate diet for normalizing blood sugar in type 2 diabetes
Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction: a Randomized Controlled Trial (CarborCal)
This study tests if a low-carbohydrate diet can help people with type 2 diabetes lower their blood sugar levels better than traditional calorie counting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 24 Years to 70 Years |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05801614 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effectiveness of a low-carbohydrate diet in normalizing blood glucose levels in patients with a short duration of type 2 diabetes. The study compares this approach to traditional caloric restriction, which can be challenging to maintain. Participants will be monitored over a period of 15 months to assess changes in HbA1c levels, which are crucial for preventing diabetes-related complications. The trial seeks to provide a less restrictive dietary alternative that can be integrated into a healthy lifestyle.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with type 2 diabetes for less than 6 years, with a BMI of 27 kg/m2 or higher.
Not a fit: Patients with severe insulin deficiency or those with HbA1c levels of 12% or more may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a sustainable dietary option for patients to manage their blood glucose levels effectively.
How similar studies have performed: Previous studies have shown that caloric restriction can normalize blood glucose levels in many patients, suggesting potential success for this less restrictive dietary approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HbA1c \> 48 mmol/mol (with or without medical treatment); * less than 6 years since the diagnosis of T2D * BMI ≥ 27 kg/m2 (≥ 25 kg/m2 for Asians). Exclusion Criteria: * Insulin deficiency. * HbA1c concentration of 12% or more (≥108 mmol/mol), * treatment with sulphonyl urea or sodium-glucose-cotrasporter2-inhibitor (SGL2-i), * myocardial infarction within the previous 6 months, * severe or unstable heart failure * other severe diseases including cancer, psychiatric/eating disorders, severe depression - substance abuse, * conditions that may affect the ability of patients to participate in the study
Where this trial is running
Stockholm
- Center for diabetes, Academic Specialist center — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Neda Rajamand Ekberg, MD, PhD — Region Stockholm
- Study coordinator: Neda Rajamand Ekberg, M.D. PhD.
- Email: neda.ekberg@ki.se
- Phone: +468-123 671 50
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.