About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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,
Trial design
Parallel
Treatments tested in this trial
Low carb diet
Other interventionLow calori diet
Treatment groups
Trial outcomes
Primary outcomes
non-diabetic HbA1c
HbA1c below 48 mmol/mol without antidiabetic medication
non diabetic HbA1c
HbA1c below 48 mmol/mol without antidiabetic medication
Secondary outcomes
Changes in HbA1c
Changes in HbA1c from base line to 3 and 15 months
Percent of participants with HbA1c below 48 and 42 mmol/mol
Number of participants with HbA1c below 48 and 42 both on and without antidiabetic medication
Changes in Fasting glucose levels
Changes in fasting plasma glucose levels after 3 and 15 months
Changes in HOMA-IR
Changes in HOMA\_IR afte 3 and 15 months
Sponsors and contacts
Click on the lead sponsor to view all of their trials.