Status:
ACTIVE_NOT_RECRUITING
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
Lead Sponsor:
Bispebjerg Hospital
Collaborating Sponsors:
University of Copenhagen
University of Aarhus
Conditions:
Diabetes Mellitus Type 2
Overweight and Obesity
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The cornerstone in the initial treatment of type 2 diabetes (T2D) is lifestyle modification, involving-among other things-a healthy diet. However, scientific evidence regarding optimal nutrition thera...
Detailed Description
Methods: This is a 12-month investigator-initiated, randomized, controlled, open-label, superiority trial with two parallel groups. The study examines the effect of a CRHP diet (which is reduced in ca...
Eligibility Criteria
Inclusion
- Men or postmenopausal women aged 18-75 years. Menopause is defined as \>12 months without menses
- Overweight or obesity with Body Mass Index (BMI) \>25 kg/m2
- Type 2 diabetes with HbA1c between 48 mmol/mol and 75 mmol/mol (6.5%-9.0%)
- Treated with or without metformin, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT-2) inhibitors and/or glucagon-like peptide 1 receptor agonists (GLP-1RA)
- Nonsmokers or having quitted smoking \>1 year before the study
- Acceptance of regulation of antidiabetic, antihypertensive, and lipid-lowering medications by Cut-DM endocrinologists only
Exclusion
- Ongoing insulin or insulin analog therapy
- Severe gut disease as evaluated by the principal investigator e.g. Crohn's disease, Ulcerative colitis, Celiac disease etc.
- Extensive surgery to the gut e.g. bariatric surgery, colectomy etc.
- Severe heart disease as evaluated by the principal investigator e.g. angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- Severe renal impairment (eGFR\<45 ml/min/1.73 m2 or urine albumin / creatinine ratio \> 300 mg/g)
- Severe hepatic impairment as evaluated by the principal investigator (measure of alanine aminotransferase (ALT) and aspartate aminotransferase (AST))
- Cancer within the last 5 years (except basal cell skin cancer or squamous cell skin cancer)
- Psychiatric disease, e.g. a history of major depressive or other severe psychiatric disorders
- Ongoing systemic corticosteroid treatment, e.g. prednisolone
- Reported or documented food allergy, food intolerance, or currently following a particular eating pattern or strong food preferences, not compatible with study participation
- Reported or documented alcohol consumption exceeding the recommendations from The Danish Health Authorities
- Ongoing treatment with sulfonylureas and/or thiazolidinediones due to the risk of hypoglycemia unless discontinuation is possible, in which case a \>3-month wash-out is mandatory
- Hemoglobin \<7 mmol/L for men and \<6 mmol/L for women
- Inability, physically and/or mentally, to comply with the procedures required by the study protocol, as evaluated by the principal investigator
- Weight change ≥5% the preceding 3 months of screening
- Participation in other on-going clinical trials
Key Trial Info
Start Date :
September 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05330247
Start Date
September 27 2022
End Date
January 1 2026
Last Update
September 12 2025
Active Locations (1)
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1
Bispebjerg Hospital
Copenhagen, Copenhagen NV, Denmark, 2400