The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
NCT ID: NCT06144593
Last Updated: 2024-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
14 participants
INTERVENTIONAL
2024-01-03
2025-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cut Down on Carbohydrate Usage in the Diet of Type 2 Diabetes. The Hypo-energetic Study
NCT03814694
Short Term Intermittent Fasting and Insulin Resistance
NCT02420054
The Acute Effects of Eucaloric and Hypocaloric Carbohydrate Restriction on Liver Fat Content and Metabolism in Obese Individuals
NCT05643521
Metabolic Impact of Intermittent Fasting in Early Type 2 Diabetes
NCT05717127
Fasting-Associated Immune-metabolic Remission of Diabetes
NCT05295160
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intermittent carbohydrate restriction
Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet.
Dietary macronutrient composition
Intermittent carbohydrate restriction
Control arm
Four weeks of free-living with no dietary restrictions.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dietary macronutrient composition
Intermittent carbohydrate restriction
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 35-75 years old
* BMI \>27 kg/m2
* Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c \>48 mmol/mol if no glucose lowering therapy
Exclusion Criteria
* TSH outside reference range
* Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
* Treatment with systemic corticosteroids
* HbA1c \>70 mmol/mol
* eGFR \<60 ml/min/1.73 m2
* Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
* Food allergies (including lactose and gluten intolerance)
* Vegetarian/vegan diet or following of specific dietary plans
* Alcohol consumptions \>84/168 g/week (women/men)
* Strenuous activity level \> 120 minutes per week
* Weight loss (\>5 kg) within the last three months or previous bariatric surgery
* High risk of fibrosis of the liver (estimated by FIB4 score \> 3.25)
35 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Copenhagen
OTHER
Danish Research Centre for Magnetic Resonance
OTHER
Hvidovre University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kirstine Nyvold Bojsen-Moeller
MD, PhD, Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Endocrinology, Hvidovre Hospital
Hvidovre, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Kirstine Nyvold Bojsen-Møller, MD, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INTERCARB - H-23043085
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.