Actively Recruiting
Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction
Led by Region Stockholm · Updated on 2024-01-02
286
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HbA1c greater than 48 mmol/mol, with or without medical treatment
- Diagnosis of type 2 diabetes less than 6 years ago
- Body mass index (BMI) of 27 kg/m2 or higher (25 kg/m2 or higher for Asians)
You will not qualify if you...
- Insulin deficiency
- HbA1c level of 12% or higher (108 mmol/mol or more)
- Treatment with sulphonyl urea or sodium-glucose cotransporter-2 inhibitors (SGLT2-i)
- Heart attack within the last 6 months
- Severe or unstable heart failure
- Other serious illnesses including cancer, psychiatric or eating disorders, severe depression, or substance abuse
- Conditions that may affect ability to participate in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Center for diabetes, Academic Specialist center
Stockholm, Sweden
Actively Recruiting
Research Team
N
Neda Rajamand Ekberg, M.D. PhD.
CONTACT
K
Katarina Fagerskiold, nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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