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

NCT05330247 | Active Not Recruiting

• 1 other identifier: CutDM - The Meal Box Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Mellitus Type 2; Overweight and Obesity

Keywords

Diabetes Mellitus Type 2; Nutrition Therapy

Outcome Measures

Primary Outcomes (1)

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

  HbA1c will be measured in fasting blood samples at baseline, 3, 6, 9 and 12 months. HbA1c will be expressed in mmol/mol.

  Baseline, 3, 6, 9 and 12 months

Secondary Outcomes (2)

• Change in total body weight after 12 months on the CRHP diet compared with the CD diet

  Baseline, 3, 6, 9 and 12 months

• Change in hepatic fat content after 12 months on the CRHP diet compared with the CD diet

  Baseline and 12 months

Other Outcomes (92)

• Change in glycemic variability (GV) after 12 months on the CRHP diet compared with the CD diet

  Baseline and 12 months

• Change in diurnal glycemia after 12 months on the CRHP diet compared with the CD diet

  Baseline and 12 months

• Change in abdominal subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) after 12 months on the CRHP diet compared with the CD diet

  Baseline and 12 months

Study Arms (2)

Therapeutic Diet: CRHP Diet

EXPERIMENTAL

Carbohydrate-reduced high-protein (CRHP) dietary intervention. Intervention: Therapeutic Diet: CRHP Diet.

Other: Carbohydrate-reduced high-protein (CRHP) Diet

Therapeutic Diet: CD Diet

ACTIVE COMPARATOR

Conventional diabetes (CD) dietary intervention. Intervention: Therapeutic Diet: CD Diet.

Other: Conventional diabetes (CD) Diet

Interventions

Carbohydrate-reduced high-protein (CRHP) Diet OTHER

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

Therapeutic Diet: CRHP Diet

Conventional diabetes (CD) Diet OTHER

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

Therapeutic Diet: CD Diet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: collaborator
• University of Aarhus: collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator
• The Købmand Niels Erik Munk Pedersen Foundation: collaborator
• Hvidovre University Hospital: collaborator
• Bispebjerg Hospital: lead
• Arla Foods: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, Copenhagen NV, 2400, Denmark

Location

Related Publications (1)

• Kopp LHP, Sogaard-Hansen CM, Zachhau KM, Bastkjaer RM, Andersen BV, Budtz-Jorgensen E, Byrne DV, Chaaban N, Holst JJ, Klindt TB, Magkos F, Ozenne B, Samkani A, Skytte MJ, Madsbad S, Krarup T, Thomsen MN. Effects of a carbohydrate-reduced high-protein diet delivered with meal kits to Danish people with type 2 diabetes: protocol for a 12-month randomised controlled trial. BMJ Open. 2024 Aug 13;14(8):e084686. doi: 10.1136/bmjopen-2024-084686.

  PMID: 39142677 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight; Obesity

Interventions

CRIP2 protein, human; Diet

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Thure Krarup, MD, DMSc

  Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

• Luise H Kopp-Nilsson, MSc, RD

  Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

  STUDY CHAIR

• Rasmus B Mainz Hansen, MD

  Dept. of Endocrinology, Copenhagen University Hospital, Bispebjerg and Frederiksberg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The endocrinologists responsible for the pharmacological regulations during the study will be blinded to the allocation of the participants. In addition, the bio-analysts performing laboratory analyses, the MR physicist responsible for evaluating MRI/MRS scans, and the individual performing DXA scans, handgrip strength and 30-second chair-stand tests will also be blinded to the allocated diet group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor, DMSc

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 15, 2022
• Study Start: September 27, 2022
• Primary Completion: March 15, 2026
• Study Completion: April 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)