RecruitingNot ApplicableNCT05801614

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

Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction: a Randomized Controlled Trial (CarborCal)

Sponsor

Region Stockholm

Enrollment

286 participants

Start Date

Feb 28, 2022

Study Type

INTERVENTIONAL

Conditions

Diabetes Mellitus Type 2 in Obese

Summary

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

Min Age: 24 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two dietary approaches — low-carbohydrate eating and calorie restriction — to see which more effectively normalizes blood sugar levels in people with recently diagnosed Type 2 diabetes. **You may be eligible if:** - You have been diagnosed with Type 2 diabetes within the past 6 years - Your HbA1c (a blood sugar measurement) is above normal (greater than 48 mmol/mol) - You are overweight or obese (BMI of 27 or higher; 25 or higher if Asian) - You are on no medication, or on certain diabetes medications **You may NOT be eligible if:** - Your blood sugar control is very poor (HbA1c of 12% or higher) - You lack sufficient insulin production (insulin deficiency) - You take sulphonylurea or SGLT2 inhibitor diabetes medications - You have had a heart attack in the last 6 months - You have severe heart failure, cancer, serious psychiatric illness, eating disorders, or severe depression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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