Active — Not RecruitingNot 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 range18 Years – 75 Years

SexALL

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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…

What they're measuring

Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet

Timeframe: Baseline, 3, 6, 9 and 12 months

Trial details

NCT IDNCT05330247

SponsorBispebjerg Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-15