Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction
Recruiting · NCT05801614 · Interventional (participants receive a specific treatment) · Lead sponsor: Region Stockholm
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This is a randomized controlled trial to determine whether a low-carbohydrate (LC) diet can lead to normalized blood glucose levels in patients with short duration of type 2 diabetes (T2D). Previous studies have shown that caloric restricted diet leading to weight loss can normalize blood glucose levels in approximately 50% of patients with a short duration of diabetes type 2. However, caloric restriction is difficult to maintain. Less restrictive approaches are needed. The hypothesis in this study is that Low carbohydrate diet can results in normalized blood glucose levels in T2D and can be an alternative to caloric restriction diet, both in the shorter term (3 months) and longer term (15 months). The outcome of this study leading to reduction of HbA1c is important for prevention of diabetes complications.
Who can take part
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 is running
1 location listed.
- Center for diabetes, Academic Specialist center - Stockholm, Sweden