NCT05801614Recruiting
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)
Source: ClinicalTrials.gov · Last updated 2 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 286 (estimated)
- First submitted
- 2 Jan 2023
- Start date
- 28 Feb 2022
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Region Stockholm
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05801614
What you commit to
- Study type: Interventional
- Planned participants: 286
- From 28 Feb 2022 to the primary completion date, 28 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- myocardial infarction within the previous 6 months,
Other illness
- 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
Lab values
- HbA1c concentration of 12% or more (≥108 mmol/mol),
- treatment with sulphonyl urea or sodium-glucose-cotrasporter2-inhibitor (SGL2-i),
Other
- Insulin deficiency.
Who the study is looking for
- 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).
Age in the registry: 24 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for diabetes, Academic Specialist center Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.