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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 24
Maximum Age: 70
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Sweden
Center for diabetes, Academic Specialist center
RECRUITING
Stockholm
Contact Information
Primary
Neda Rajamand Ekberg, M.D. PhD.
neda.ekberg@ki.se
+468-123 671 50
Backup
Katarina Fagerskiold, nurse
katarina.fagerskiold@regionstockholm.se
+468-123 671 76
Time Frame
Start Date: 2022-02-28
Estimated Completion Date: 2027-02-28
Participants
Target number of participants: 286
Treatments
Other: Low Carb diet
Participants will have acces to a plattform with recepies containing 30 g carbohydrate / day during the first three months and thereafter recepies containing 80 g carbohydrate/ day during the remaining 12 months
Other: Low Calori diet
Participants will be asked to by low caloric diet replacement containing 850 kCal/day during the first 3 months, aiming for a weight loss of 10 kg during and thereafter will have access to recepies containing less calorie for weight maintenance during the remaining 12 months
Related Therapeutic Areas
Sponsors
Leads: Region Stockholm

This content was sourced from clinicaltrials.gov