Clinical trial Recruiting at 1 site Interventional Ages 24 to 70

Low-carbohydrate diet for normalizing blood sugar in type 2 diabetes

Official title: Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction: a Randomized Controlled Trial (CarborCal)

Run by Region Stockholm · NCT05801614 · Data updated 2026-11-12

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

Study typeInterventional
Ages24 Years to 70 Years
SexAll
Enrollment286 (estimated)
SponsorRegion Stockholm
Government
Locations1 site (Stockholm)
StatusRecruiting
StartedFebruary 28, 2022
Main results expectedFebruary 28, 2027
Study endsFebruary 28, 2027
Registry record updatedJanuary 2, 2024
Trial IDNCT05801614 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with severe insulin deficiency or those with HbA1c levels of 12% or more may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Previous studies have shown that caloric restriction can normalize blood glucose levels in many patients, suggesting potential success for this less restrictive dietary approach.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.