Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction
Recruiting now · Not applicable
Conditions studied: Diabetes Mellitus Type 2 in Obese
In brief
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.
Key facts
- Study ID
- NCT05801614
- Run by
- Region Stockholm
- People needed
- 286
- Starts
- 2022-02-28
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2024-01-02
Who can join
Age: 24 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
- Center for diabetes, Academic Specialist center — Stockholm, Sweden (enrolling)
Full record on ClinicalTrials.gov
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