NCT05801614

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Feb 2022Feb 2027

Study Start

First participant enrolled

February 28, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 6, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

5 years

First QC Date

January 2, 2023

Last Update Submit

December 27, 2023

Conditions

Diabetes Mellitus Type 2 in Obese

Keywords

Diabetes Mellitus Type 2DietCarbohydrate-RestrictedCaloric restriction

Outcome Measures

Primary Outcomes (2)

  • non-diabetic HbA1c

    HbA1c below 48 mmol/mol without antidiabetic medication

    After 3 months

  • non diabetic HbA1c

    HbA1c below 48 mmol/mol without antidiabetic medication

    After 15 months

Secondary Outcomes (5)

  • Changes in HbA1c

    After 3 and 15 months

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

    After 3 and 15 months

  • Changes in Fasting glucose levels

    After 3 and 15 months

  • Changes in HOMA-IR

    After 3 and 15 months

  • Changes in Insulin secretion

    After 3 and 15 months

Study Arms (2)

Low Carb diet

OTHER

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 carb diet

Low Calori diet

OTHER

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

Other: Low carb diet

Interventions

Low carb dietOTHER

Low calori diet

Also known as: Low calori diet
Low Calori dietLow Carb diet

Eligibility Criteria

Age24 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for diabetes, Academic Specialist center

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Neda Rajamand Ekberg, MD, PhD

    Region Stockholm

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neda Rajamand Ekberg, M.D. PhD.

CONTACT

+468-123 671 50neda.ekberg@ki.se

Katarina Fagerskiold, nurse

CONTACT

+468-123 671 76katarina.fagerskiold@regionstockholm.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant physician, associate professor

Study Record Dates

First Submitted

January 2, 2023

First Posted

April 6, 2023

Study Start

February 28, 2022

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)