NCT05801614 Normalized Glucose Levels in Type 2 Diabetes With Carbohydrate or Caloric Restriction
| NCT ID | NCT05801614 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Region Stockholm |
| Condition | Diabetes Mellitus Type 2 in Obese |
| Study Type | INTERVENTIONAL |
| Enrollment | 286 participants |
| Start Date | 2022-02-28 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 286 participants in total. It began in 2022-02-28 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Neda Rajamand Ekberg, MD, PhD
PRINCIPAL INVESTIGATOR
Region Stockholm
Frequently Asked Questions
Who can join the NCT05801614 clinical trial?
This trial is open to participants of all sexes, aged 24 Years or older, up to 70 Years, studying Diabetes Mellitus Type 2 in Obese. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05801614 currently recruiting?
Yes, NCT05801614 is actively recruiting participants. Contact the research team at neda.ekberg@ki.se for enrollment information.
Where is the NCT05801614 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT05801614 clinical trial?
NCT05801614 is sponsored by Region Stockholm. The principal investigator is Neda Rajamand Ekberg, MD, PhD at Region Stockholm. The trial plans to enroll 286 participants.
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