NCT05330247Completed
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes Mellitus - The Meal Box Study
Source: ClinicalTrials.gov · Last updated 9 Jul 2026
Brief summary (registry, in English)
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 therapy for patients with T2D is insufficient. This clinical study will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared to a conventional diabetes (CD) diet for 12 months on metabolic function and body weight in patients with T2D. The hypothesis of the study is that the CRHP diet will improve metabolic control and the cardiovascular risk profile of patients with T2D to a greater extent than the CD diet. In particular, the expectation is that, compared with the CD diet, the CRHP diet will: * Reduce diurnal and postprandial glycemia measured by continuous glucose monitoring (CGM) and thereby facilitate a significant reduction of glycated hemoglobin (HbA1c) * Reduce body weight * Reduce ectopic fat deposition in the liver and the pancreas * Improve the blood lipid profile * Reduce or not affect blood pressure with no adverse effect on heart rate variability * Increase insulin sensitivity and secretion * Decrease inflammatory markers in the blood * Improve satiety * Reduce or not affect the need for antidiabetic, antihypertensive and/or lipid-lowering medications To reinforce the results and knowledge generated from the primary study, participants will be invited to partake in a 12-month follow-up period after the initial 12 months of intervention.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 23 Mar 2022
- Start date
- 27 Sept 2022
- Primary completion date
- 29 Jan 2026
- Lead sponsor
- Bispebjerg Hospital
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05330247
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 27 Sept 2022 to the primary completion date, 29 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing insulin or insulin analog therapy
- Extensive surgery to the gut e.g. bariatric surgery, colectomy etc.
- Ongoing systemic corticosteroid treatment, e.g. prednisolone
- 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
Other illness
- Severe gut disease as evaluated by the principal investigator e.g. Crohn's disease, Ulcerative colitis, Celiac disease etc.
- Severe heart disease as evaluated by the principal investigator e.g. angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- 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
- Reported or documented food allergy, food intolerance, or currently following a particular eating pattern or strong food preferences, not compatible with study participation
Lab values
- 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))
- Hemoglobin \<7 mmol/L for men and \<6 mmol/L for women
Other
- Reported or documented alcohol consumption exceeding the recommendations from The Danish Health Authorities
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.