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

Plain English Summary

Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study is a Not Applicable clinical trial sponsored by Bispebjerg Hospital studying Diabetes Mellitus Type 2, Overweight and Obesity. This study tests a low-carbohydrate, high-protein diet against a standard diabetes diet for 12 months. It's for adults with type 2 diabetes who are overweight or obese. Participants will follow one of the two diets and have regular check-ups. Alternatives include other dietary changes, exercise, and various diabetes medications. The trial aims to enroll 100 participants.

Official 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

Here is what you need to know about eligibility for this trial. Adults aged 18-75 who are overweight or obese (BMI > 25) and have type 2 diabetes. Must have an HbA1c between 6.5% and 9.0% and be on certain diabetes medications (or none). Cannot be on insulin, have severe gut, heart, kidney, or liver problems, or have had cancer recently. Must not have food allergies incompatible with the diets or be currently on systemic corticosteroids. This trial is studying Diabetes Mellitus Type 2, Overweight and Obesity, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how well each diet controls blood sugar levels (HbA1c) and reduces body weight over a year. The specific primary outcome measures are: Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet (Baseline, 3, 6, 9 and 12 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to find the best diet for managing type 2 diabetes, addressing a gap in understanding optimal nutrition therapy. This research targets Diabetes Mellitus Type 2, Overweight and Obesity, where improved treatment options are needed.

Investor Insight

This trial explores a dietary intervention for a large patient population, potentially impacting the diabetes management market if successful.

Is This Trial Right for Me?

Ask your doctor if a low-carbohydrate, high-protein diet is suitable for your diabetes management. You will follow a specific diet plan and attend regular study visits for monitoring. Your diabetes medications may be adjusted by the study doctors. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: SINGLE
• Enrollment: 100 participants

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.

Primary Outcomes

• Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet (Baseline, 3, 6, 9 and 12 months)

Secondary Outcomes

• 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)

Full Eligibility Criteria

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

Trial Locations

• Bispebjerg Hospital, Copenhagen, Copenhagen NV, Denmark

Frequently Asked Questions

Related Conditions

• Diabetes Mellitus Type 2
• Overweight
• Obesity
• Metabolic Syndrome
• Insulin Resistance
• Cardiovascular Risk
• Hypertension
• Dyslipidemia
• Non-alcoholic Fatty Liver Disease
• Dietary Therapy

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