Diet Modification for Type 2 Diabetes

(LEGEND Trial)

Recruiting at 1 trial location

Overseen By Rick Hecht, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Weight loss medications, Systemic steroids

Disqualifiers: Pregnancy, Bariatric surgery, Vegan, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is being completed to compare two dietary approaches for participants with type 2 diabetes. This research will test whether a very low-carbohydrate or a plate-method diet better improves outcomes for blood glucose control and body composition for patients with type 2 diabetes that follow one of these approaches for 12 months. Participants that meet screening and eligibility will be randomized to one of the two diets. In addition to the diet, study specific visits and assessments will be performed at various timepoints.

Will I have to stop taking my current medications?

If you are taking an SGLT2 inhibitor medication, you will need to stop it if you are assigned to the very low-carbohydrate diet. The protocol does not specify about other medications.

Is a low-carbohydrate or ketogenic diet safe for humans?

Research indicates that low-carbohydrate and ketogenic diets are generally safe for humans, including those with type 2 diabetes, though concerns about safety remain. These diets have been shown to be well-tolerated and can lead to weight loss and improved health outcomes in some cases. ^{1 2 3 4 5}

How is the diet modification treatment for type 2 diabetes different from other treatments?

This treatment is unique because it uses a moderate-carbohydrate plate-method diet and a very low-carbohydrate ketogenic diet, which focus on reducing carbohydrate intake to manage blood sugar levels, unlike traditional treatments that may rely more on medication. ^{3 5 6 7 8}

What data supports the effectiveness of the treatment for type 2 diabetes?

Research shows that very low-carbohydrate and ketogenic diets can help improve blood sugar levels and reduce the need for diabetes medications in people with type 2 diabetes. Additionally, these diets can lead to significant weight loss, which is beneficial for managing diabetes. ^{5 6 7 9 10}

Who Is on the Research Team?

Laura Saslow, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with type 2 diabetes, who have an HbA1c level between 6.5% and <12%, can do light exercise, and are willing to follow a new diet plan for a year. Pregnant women, those over 400 pounds, or on certain diets or medications are excluded.

Inclusion Criteria

I am willing to follow any diet assigned to me in the study.

I have type 2 diabetes with an HbA1c level between 6.5% and 12%.

I have type 2 diabetes with an HbA1c level between 6.5% and 12%.

Exclusion Criteria

I have had kidney stones multiple times or recently.

I am currently in a weight loss program or plan to join one soon.

I am willing and able to attend study sessions and classes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either a very low-carbohydrate or a plate-method diet for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moderate-carbohydrate plate-method diet
• Very low-carbohydrate diet

Trial Overview The study compares two diets: a moderate-carbohydrate plate-method diet versus a very low-carbohydrate diet to see which one better improves blood sugar control and body weight in type 2 diabetes patients over the course of one year.

How Is the Trial Designed?

Group I: Very low-carbohydrate diet Experimental Treatment 1 Intervention

Group II: Moderate-carbohydrate plate-method diet Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

In a 16-week study involving 28 overweight participants with type 2 diabetes, the low-carbohydrate, ketogenic diet (LCKD) led to a significant 16% reduction in hemoglobin A1c levels, indicating improved glycemic control.

The diet also allowed for the discontinuation or reduction of diabetes medications in 17 out of 21 participants who completed the study, highlighting the need for close medical supervision when implementing such dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. Yancy, WS., Foy, M., Chalecki, AM., et al.[2020]

The modified Atkins diet, a less restrictive version of the ketogenic diet, has shown good efficacy and tolerability in treating refractory epilepsy, making it a promising dietary intervention.

This diet can be initiated on an outpatient basis without fasting, allowing unlimited protein and fat intake, which may improve adherence compared to more restrictive diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The modified atkins diet in refractory epilepsy. Sharma, S., Jain, P.[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]

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 21-day very low-calorie ketogenic diet (VLCKD) resulted in significant weight loss and improvements in insulin resistance without negatively impacting overall nutritional status or causing adverse changes in liver and kidney function.

Both VLCKD1 and VLCKD2 led to similar reductions in body mass index and fat mass, but also resulted in increased levels of uric acid and creatinine, indicating the need for monitoring these parameters during such diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. Colica, C., Merra, G., Gasbarrini, A., et al.[2022]

A 42-year-old woman with type 2 diabetes experienced euglycemic diabetic ketoacidosis (euDKA) after starting a sodium-glucose co-transporter 2 (SGLT2) inhibitor while on a very low carbohydrate ketogenic diet (VLCKD), highlighting the risk of this combination.

After recovering from euDKA and stopping the SGLT2 inhibitor, she successfully resumed a VLCKD under medical supervision and maintained ketosis safely for 2 years, demonstrating that with proper monitoring, VLCKD can be safely reimplemented post-euDKA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. Fieger, EI., Fadel, KM., Modarres, AH., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness of restricted diet with a plate in patients with type 2 diabetes: A randomized controlled trial. [2022]

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

Very Low and Higher Carbohydrate Diets Promote Differential Appetite Responses in Adults with Type 2 Diabetes: A Randomized Trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Very low carbohydrate (ketogenic) diets in type 2 diabetes: A systematic review and meta-analysis of randomized controlled trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A low-carbohydrate, ketogenic diet to treat type 2 diabetes. [2020]

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

Severe type 2 diabetes (T2D) remission using a very low-calorie ketogenic diet (VLCKD). [2023]

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

The modified atkins diet in refractory epilepsy. [2022]

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

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

8. 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]

9. Italy pubmed.ncbi.nlm.nih.gov

Efficacy and safety of very-low-calorie ketogenic diet: a double blind randomized crossover study. [2022]

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

SUCCESSFUL REIMPLEMENTATION OF A VERY LOW CARBOHYDRATE KETOGENIC DIET AFTER SGLT2 INHIBITOR ASSOCIATED EUGLYCEMIC DIABETIC KETOACIDOSIS. [2022]