Clinical trial

Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction

Recruiting now · Not applicable · 1 countries · Registry ID NCT05801614

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age24 Years to 70 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabetes Mellitus Type 2 in Obese

Full registry 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

Treatments and study arms

Low carb diet

Other

Low calori diet

Primary outcomes

non-diabetic HbA1cAfter 3 months

HbA1c below 48 mmol/mol without antidiabetic medication

non diabetic HbA1cAfter 15 months

HbA1c below 48 mmol/mol without antidiabetic medication

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center for diabetes, Academic Specialist center🇸🇪 Stockholm, Sweden

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Katarina Fagerskiold, nurseContact

Email · Call +46-8-123 671 76.

Neda Rajamand Ekberg, M.D; PhDPrincipal Investigator