Actively Recruiting
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Led by Hvidovre University Hospital · Updated on 2024-06-06
14
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
H
Hvidovre University Hospital
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.
CONDITIONS
Official Title
The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women
- Aged 35 to 75 years
- Body mass index (BMI) greater than 27 kg/m2
- Known type 2 diabetes with stable glucose-lowering therapy for at least three months or HbA1c greater than 48 mmol/mol if not on glucose-lowering therapy
You will not qualify if you...
- Anemia with hemoglobin less than 8 mmol/L for men and less than 7 mmol/L for women
- Thyroid stimulating hormone (TSH) levels outside the normal range
- Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
- Treatment with systemic corticosteroids
- HbA1c greater than 70 mmol/mol
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2
- Contraindications for MRI such as abdominal size exceeding scanner limits, pacemaker or implanted electronic devices, implanted metal devices, or severe claustrophobia
- Food allergies including lactose or gluten intolerance
- Following vegetarian, vegan, or specific dietary plans
- Alcohol consumption exceeding 84 g/week for women or 168 g/week for men
- Strenuous physical activity exceeding 120 minutes per week
- Weight loss over 5 kg within the last three months or previous bariatric surgery
- High risk of liver fibrosis estimated by FIB4 score greater than 3.25
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Endocrinology, Hvidovre Hospital
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
A
Amanda Schaufuss, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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