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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-70
SponsorRegion Stockholm

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low carb diet

    Other intervention

    Low calori diet

Treatment groups

286 Participants
are divided into 2 treatment groups
Group A: Low Carb dietOther 1 intervention
Group B: Low Calori dietOther 1 intervention

Trial outcomes

Primary outcomes

1

non-diabetic HbA1c

HbA1c below 48 mmol/mol without antidiabetic medication

Time frame
After 3 months
2

non diabetic HbA1c

HbA1c below 48 mmol/mol without antidiabetic medication

Time frame
After 15 months

Secondary outcomes

1

Changes in HbA1c

Changes in HbA1c from base line to 3 and 15 months

Time frame
After 3 and 15 months
2

Percent of participants with HbA1c below 48 and 42 mmol/mol

Number of participants with HbA1c below 48 and 42 both on and without antidiabetic medication

Time frame
After 3 and 15 months
3

Changes in Fasting glucose levels

Changes in fasting plasma glucose levels after 3 and 15 months

Time frame
After 3 and 15 months
4

Changes in HOMA-IR

Changes in HOMA\_IR afte 3 and 15 months

Time frame
After 3 and 15 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.