Dietary Intervention for Type 2 Diabetes

(DECIDE Trial)

Overseen By Barbara Oliveira, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Heart disease, Liver disease, Kidney disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Type 2 diabetes is typically viewed as a chronic, progressive, and lifelong condition. Patients and their healthcare providers "manage" type 2 diabetes through lifestyle modifications and various types of medications designed to lower blood sugar. Exciting new research indicates that "remission" of type 2 diabetes - defined as returning blood sugar into the normal range without having to use medications - through therapeutic nutrition may be possible for many people living with the condition. We will examine the preference, adherence and clinical results of a low-calorie diet or low-carbohydrate diet in type 2 diabetes remission rates.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is the dietary intervention for Type 2 Diabetes safe for humans?

Research indicates that low-calorie and low-carbohydrate diets, including very low-calorie diets, are generally safe for people with Type 2 Diabetes, though concerns about safety remain. These diets have been shown to help with weight loss and improve health markers, but it's important to discuss any dietary changes with a healthcare provider. ^{1 2 3 4 5}

How does the low-calorie or low-carbohydrate diet treatment for type 2 diabetes differ from other treatments?

This treatment is unique because it focuses on dietary changes, specifically low-calorie or low-carbohydrate diets, which can lead to improved blood sugar control and even remission of type 2 diabetes in some patients. Unlike standard treatments that often rely on medication, this approach emphasizes nutrition and lifestyle changes, potentially reducing the need for diabetes medications. ^{2 4 6 7 8}

What data supports the effectiveness of the dietary treatment for Type 2 Diabetes?

Research shows that low-calorie and low-carbohydrate diets can improve blood sugar control in people with Type 2 Diabetes, with some reports of remission. Very low-calorie diets are effective for initial weight loss and improving blood sugar levels, although long-term results may vary. ^{2 6 9 10 11}

Are You a Good Fit for This Trial?

This trial is for adults aged 20-80 with Type 2 Diabetes, an HbA1c level of at least 6.0%, and a BMI over 27 kg/m2. Participants should be able to follow a low-calorie or low-carbohydrate diet without dietary restrictions and must have internet access. Those who've recently lost weight, had bariatric surgery, severe mental health issues, recent serious illnesses like cancer or heart disease, eating disorders, or are pregnant can't join.

Inclusion Criteria

Your HbA1c level is 6.0% or higher.

You weigh more than what is considered healthy for your height.

I am between 20 and 80 years old.

Exclusion Criteria

I have lost 5% or more of my weight in the past 6 months.

I have a history of liver disease.

You have food allergies or dietary restrictions that would make it hard for you to follow the diet plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Weight Loss and Medication Deprescribing

Participants undergo a weight loss program and medication deprescribing

12 weeks

In-person and virtual appointments

Phase 2: Transition to Sustainable Dietary Pattern

Participants transition to an individualized sustainable dietary pattern

8 weeks

Virtual visits

Phase 3: Weight Loss/Remission Maintenance

Participants maintain weight loss and diabetes remission

32 weeks

In-person and virtual appointments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Low-calorie diet or low-carbohydrate diet

Trial Overview The study explores whether Type 2 Diabetes can go into remission through diet alone—without medications. It compares the effectiveness of a low-calorie diet versus a low-carbohydrate diet on lowering blood sugar levels to normal ranges.

How Is the Trial Designed?

Group I: Low-carbohydrate diet group Experimental Treatment 1 Intervention

The low-carbohydrate diet will involve an individualized whole-food diet (30-130 grams carbohydrate per day) led through virtual visits with a registered dietitian.

Group II: Low-calorie diet group Experimental Treatment 1 Intervention

A low-calorie diet involving will involve a commercial weight loss program (pre-packaged foods from Ideal Protein, select lean protein sources, non-starchy vegetables) and be led by the pharmacist and registered dietitian (RD) involving in-person and virtual appointments.

Low-calorie diet or low-carbohydrate diet is already approved in European Union, United Kingdom, United States for the following indications:

Approved in European Union as Therapeutic Nutrition for:

• Type 2 Diabetes Remission

Approved in United Kingdom as Low-Calorie Diet for:

• Type 2 Diabetes Remission

Approved in United States as Low-Carbohydrate Diet for:

• Type 2 Diabetes Management

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Published Research Related to This Trial

Nutritional therapy for type II diabetes can be effective, but it requires realistic weight loss goals and proper meal planning, including meal splitting and carbohydrate distribution, rather than just cutting out carbs.

Not all type II diabetic patients respond to dietary changes alone; some may need additional treatments like oral medications or insulin, and involving dieticians can enhance long-term success in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Why does nutrition therapy so often fail in non-insulin-dependent diabetes? What measures bring success?]. Keller, U.[2015]

Very low energy diets (VLEDs) are effective for significant weight loss in overweight or obese adults with Type 2 diabetes, showing greater weight loss compared to standard care and minimal interventions over 3 and 6 months, based on a meta-analysis of 9 studies with 346 participants.

Adherence to VLEDs appears to be high, with no significant differences in attrition rates compared to other interventions, although the support provided to participants during the diet was often not well documented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses. Rehackova, L., Arnott, B., Araujo-Soares, V., et al.[2022]

Strong evidence indicates that the total amount of carbohydrates consumed is more crucial for managing diabetes than the specific type of carbohydrate, highlighting the importance of portion control and meal planning.

Nutrition therapy is effective in achieving treatment goals for blood sugar, lipids, and blood pressure in individuals with type 2 diabetes, and ongoing monitoring is essential to evaluate the effectiveness of lifestyle changes and medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. Franz, MJ.[2015]

Weight loss is crucial for managing type 2 diabetes, with dietary changes showing immediate improvements in blood sugar control, but these effects tend to diminish over time, especially if energy restrictions are relaxed.

Comprehensive lifestyle interventions combining diet, exercise, and behavioral changes can lead to modest weight loss (2 to 10 kg) in the short term, but many individuals regain a significant portion of this weight within a year, highlighting the need for innovative long-term strategies to sustain weight loss and improve glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary treatment and long-term weight loss and maintenance in type 2 diabetes. Hensrud, DD.[2016]

This feasibility trial will assess a low-carbohydrate, low-energy diet intervention for 30 adults with type 2 diabetes over 12 weeks, aiming to determine if a behavioral support program can be effectively implemented in primary care settings.

The primary goal is to see if at least 60% of participants attempt the diet and attend follow-up sessions, with secondary outcomes including changes in blood glucose levels and weight, which could inform future larger-scale studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial. Morris, E., Aveyard, P., Dyson, P., et al.[2022]

In a study involving 89 participants with type 2 diabetes, a very low-calorie ketogenic (VLCK) diet led to significantly greater weight loss and improved glycemic control compared to a standard low-calorie diet over 4 months.

The VLCK diet was found to be safe and well-tolerated, with no serious adverse events reported and no significant changes in laboratory safety parameters, indicating it can be a viable option for managing obesity in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. Goday, A., Bellido, D., Sajoux, I., et al.[2022]

A very-low-calorie diet (VLCD) of 600 kcal/day was effective in inducing short-term remission of type 2 diabetes in 79% of the 19 Thai patients studied, with significant improvements in glycemic control and beta cell function observed within the first 2 weeks.

After 12 months, about 30% of participants maintained diabetes remission without medication, indicating that while VLCD can provide rapid benefits, long-term maintenance of glycemic control may require additional strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. Umphonsathien, M., Prutanopajai, P., Aiam-O-Ran, J., et al.[2023]

In a study of 229 obese type 2 diabetic patients over 24 weeks, a protein-sparing modified formula diet (FD) led to significantly greater weight loss (-3.5 kg) compared to a conventional low-caloric diet (CD) (-1.4 kg), indicating its efficacy for weight management.

The FD group also showed more significant improvements in metabolic health, including greater reductions in HbA1c and increases in HDL-cholesterol, suggesting that this diet not only aids in weight loss but also enhances cardiovascular risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of partial use of formula diet on weight reduction and metabolic variables in obese type 2 diabetic patients--multicenter trial. Shirai, K., Saiki, A., Oikawa, S., et al.[2022]

Low-carbohydrate diets have shown positive results in treating diabetes, pre-diabetes, metabolic syndrome, and obesity, with evidence from randomized trials and meta-analyses indicating they are safe and effective for improving health outcomes in diabetic patients.

These diets can lead to significant benefits such as weight loss, reduced medication needs, and even remission in some cases of type 2 diabetes, although they are not yet widely recognized in Czech diabetology due to ongoing safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. Krejčí, H., Vyjídák, J., Kohutiar, M.[2019]

Diabetes-specific nutrition formulas (DSNFs) are designed with slowly-digestible carbohydrates and healthy fats, showing significant improvements in post-meal blood sugar levels and long-term glycemic control in patients with type 2 diabetes (T2D).

Clinical trials indicate that DSNFs not only help manage blood sugar levels but also positively impact various cardiometabolic health outcomes, making them a valuable tool in nutrition therapy for T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? Noronha, JC., Mechanick, JI.[2023]

A very-low-calorie ketogenic diet (VLCKD) led to significant weight loss and improved glycemic control in patients with obesity and type 2 diabetes, with BMI and HbA1c levels showing marked reductions over 12 months compared to a standard low-calorie diet (LCD).

The VLCKD group also reported better quality of life and eating behavior, with a notable 26.6% of participants able to stop all antidiabetic medications, while the LCD group saw an increase in medication needs for 46.6% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes. Moriconi, E., Camajani, E., Fabbri, A., et al.[2022]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Why does nutrition therapy so often fail in non-insulin-dependent diabetes? What measures bring success?]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and acceptability of very low energy diets in overweight and obese people with Type 2 diabetes mellitus: a systematic review with meta-analyses. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary treatment and long-term weight loss and maintenance in type 2 diabetes. [2016]

5. England pubmed.ncbi.nlm.nih.gov

Dietary Approaches to the Management Of type 2 Diabetes (DIAMOND): protocol for a randomised feasibility trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Immediate and long-term effects of a very-low-calorie diet on diabetes remission and glycemic control in obese Thai patients with type 2 diabetes mellitus. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of partial use of formula diet on weight reduction and metabolic variables in obese type 2 diabetic patients--multicenter trial. [2022]

9. Czech Republic pubmed.ncbi.nlm.nih.gov

Low-carbohydrate diet in diabetes mellitus treatment. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Is There a Role for Diabetes-Specific Nutrition Formulas as Meal Replacements in Type 2 Diabetes? [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Very-Low-Calorie Ketogenic Diet as a Safe and Valuable Tool for Long-Term Glycemic Management in Patients with Obesity and Type 2 Diabetes. [2022]