Actively Recruiting

Phase Not Applicable
Age: 24Years - 70Years
All Genders
NCT05801614

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

Led by Region Stockholm · Updated on 2024-01-02

286

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 24Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • HbA1c greater than 48 mmol/mol, with or without medical treatment
  • Diagnosis of type 2 diabetes less than 6 years ago
  • Body mass index (BMI) of 27 kg/m2 or higher (25 kg/m2 or higher for Asians)
Not Eligible

You will not qualify if you...

  • Insulin deficiency
  • HbA1c level of 12% or higher (108 mmol/mol or more)
  • Treatment with sulphonyl urea or sodium-glucose cotransporter-2 inhibitors (SGLT2-i)
  • Heart attack within the last 6 months
  • Severe or unstable heart failure
  • Other serious illnesses including cancer, psychiatric or eating disorders, severe depression, or substance abuse
  • Conditions that may affect ability to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Center for diabetes, Academic Specialist center

Stockholm, Sweden

Actively Recruiting

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Research Team

N

Neda Rajamand Ekberg, M.D. PhD.

CONTACT

K

Katarina Fagerskiold, nurse

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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