Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study (NCT05330247) | Clinical Trial Compass
CompletedNot Applicable
Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study
Denmark100 participantsStarted 2022-09-27
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Ongo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet