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ACTIVE NOT RECRUITING

NCT05330247

Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study

Sponsor: Bispebjerg Hospital

View on ClinicalTrials.gov

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.

Official title: Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes Mellitus - The Meal Box Study

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-09-27

Completion Date

2026-04

Last Updated

2026-02-18

Healthy Volunteers

Conditions

Diabetes Mellitus Type 2 Overweight and Obesity

Interventions

OTHER

Carbohydrate-reduced high-protein (CRHP) Diet

Macronutrient intake of 30 percentage of energy from carbohydrate, 30 percentage of energy from protein and 40 percentage of energy from fat.

OTHER

Conventional diabetes (CD) Diet

Macronutrient intake of 50 percentage of energy from carbohydrate, 17 percentage of energy from protein and 33 percentage of energy from fat.

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 * 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

Locations (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, Denmark