Personalized Dietary Management for Type 2 Diabetes

(DiaTeleMed Trial)

Overseen By Lu Hu, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: Metformin

Must not be taking: Antibiotics, Antifungals, Steroids, others

Disqualifiers: Pregnancy, Chronic disease, Gastrointestinal disorder, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different dietary approaches can help manage early-stage Type 2 Diabetes. Participants are divided into three groups: one receives personalized advice to reduce blood sugar spikes after meals (Personalized Guidance to Minimize Postprandial Glycemic Response), another follows a standard Mediterranean diet (Isocaloric Mediterranean Diet Advice), and the last receives general advice. It is ideal for adults managing their diabetes with lifestyle changes and metformin, who can track their diet using a smartphone.

As an unphased trial, it provides a unique opportunity to explore personalized dietary strategies for improved diabetes management.

Do I have to stop taking my current medications for the trial?

The trial requires that participants are only on metformin for diabetes management and have not taken antibiotics, antifungals, or other specified medications in the past 3 months. If you are on other diabetic medications or certain other drugs, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that following a Mediterranean diet is generally safe and easy for most people. It can lower the risk of developing type 2 diabetes and improve overall health. Many who switch to this diet see their diabetes risk drop significantly, sometimes by more than 50%.

For personalized advice to help manage blood sugar levels after eating, studies highlight its potential benefits. This approach provides tailored advice based on how different foods affect the body. Research suggests this method is safe for most people and doesn't cause major side effects.

Standardized dietary counseling is another way to manage type 2 diabetes. Research supports its safety and effectiveness in controlling blood sugar levels without causing harmful effects.

Current research considers all these methods safe. Participants usually don't experience significant negative effects. Always consult a healthcare provider before changing your diet, especially if considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the personalized dietary management approach for Type 2 Diabetes because it offers a tailored method to minimize postprandial glycemic response (PPGR). Unlike standard care, which often involves general advice on a Mediterranean diet, the personalized approach uses specific guidance to help individuals manage their blood sugar levels more effectively after meals. Additionally, the use of Social Cognitive Theory (SCT)-based behavioral counseling helps patients incorporate these dietary changes into their daily lives more sustainably. This personalized strategy could lead to better blood sugar control and overall diabetes management, offering a more customized and potentially more effective option than existing one-size-fits-all dietary advice.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research shows that personalized advice to reduce blood sugar spikes after meals can help manage blood sugar levels. In this trial, participants in the "Personalized" arm will receive dietary counseling to follow a Mediterranean-style diet tailored to reduce postprandial glycemic response. Some studies have used advanced computer programs to predict these spikes, showing promise for better diet management in people with Type 2 Diabetes (T2D). Another study used information about gut bacteria to tailor diets, which also showed potential in controlling blood sugar levels.

Additionally, following a Mediterranean diet with the same calorie intake has been shown to help prevent T2D. Participants in the "Standardized" arm of this trial will receive one-size-fits-all dietary counseling to follow a Mediterranean-style diet. Research has found that this diet can lower the risk of diabetes by up to 31% over several years. It also helps control blood sugar and reduces heart disease risk factors in people with diabetes. These findings suggest that both personalized advice and the Mediterranean diet can effectively manage T2D. ^{1 5 6 7 8}

Who Is on the Research Team?

Collin J Popp, PhD, RD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

Adults aged 21-80 with early-stage Type 2 Diabetes (T2D), HbA1c<8%, on a stable diabetes regimen including metformin, able to use a smartphone and attend online sessions. Excludes those with certain chronic diseases, unable or unwilling to follow the diet plan, pregnant women, those with limited mobility or control over their diet, substance abusers, and people on specific medications.

Inclusion Criteria

Those who are willing and able to use a smart phone to self monitor their diet and to attend WebEx sessions

I have early-stage Type 2 Diabetes with HbA1c under 8%, managed with lifestyle changes and metformin for the past 3 months.

I am between 21 and 80 years old.

Exclusion Criteria

Those who are unable or unwilling to adhere to an intervention that requires dietary self-monitoring

You have limited control over what you eat, for example, if you are homeless, in a nursing home, or in jail.

I have been diagnosed with a long-term inflammatory or cancerous disease in the last 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Randomization and Initial Intervention

Participants are randomized into Standardized, Personalized, or Usual Care Control groups and receive initial dietary counseling and education

0-3 months

1 visit (in-person) at baseline

Intervention Continuation

Participants continue with their assigned dietary intervention and receive ongoing counseling

3-6 months

1 visit (in-person) at 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Isocaloric Mediterranean Diet Advice
• Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)
• SCT-Based Behavioral Counseling
• Standardized
• Usual Care Control (UCC)

Trial Overview

The trial is testing how effective personalized dietary guidance is at managing blood sugar after meals compared to standardized advice and usual care in people with T2D. It randomly assigns participants into three groups: Standardized Guidance Group, Personalized Guidance Group, or Usual Care Control Group.

How Is the Trial Designed?

Group I: Usual Care Control (UCC) Experimental Treatment 1 Intervention

Baseline advice about the Mediterranean-style diet and attention control.

Group II: Personalized Active Control 3 Interventions

Dietary counseling to follow a Mediterranean-style diet personalized to reduce postprandial glycemic response

Group III: Standardized Active Control 2 Interventions

One-size-fits-all dietary counseling to follow a Mediterranean-style diet

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

A personalized postprandial-targeting (PPT) diet significantly improved glycemic control in individuals with newly diagnosed type 2 diabetes mellitus (T2DM) compared to a Mediterranean-style (MED) diet, with notable reductions in average postprandial glucose responses and time spent above normal glucose levels.

After a 6-month PPT intervention, 61% of participants achieved diabetes remission, demonstrating the long-term efficacy of the PPT diet in improving metabolic health parameters such as HbA1c and fasting glucose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of personalized diets by prediction of glycemic responses on glycemic control and metabolic health in newly diagnosed T2DM: a randomized dietary intervention pilot trial. Rein, M., Ben-Yacov, O., Godneva, A., et al.[2022]

In a study of 136 Japanese adults with type 2 diabetes, individualized dietary advice led to a greater reduction in HbA1c levels (-1.1%) compared to conventional dietary advice (-0.7%) over 6 months, indicating its effectiveness in managing blood sugar levels.

Participants receiving individualized advice also made healthier dietary changes, such as reducing energy intake and consumption of sweets and fats, which contributed to improvements in weight and lipid profiles, although these changes were not significantly different from the conventional group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of individualized dietary advice compared with conventional dietary advice for adults with type 2 diabetes: A randomized controlled trial. Omura, Y., Murakami, K., Matoba, K., et al.[2022]

The Personal Diet Study is investigating the effectiveness of two dietary interventions for weight loss in individuals with prediabetes and type 2 diabetes: a standard low-fat diet and a personalized diet based on machine-learning predictions of glycemic response.

The study will assess changes in body weight, body composition, and resting energy expenditure over a 6-month intervention period, followed by a 6-month observation period to evaluate the maintenance of weight loss, utilizing mobile health technology for behavioral support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rationale and design of the personal diet study, a randomized clinical trial evaluating a personalized approach to weight loss in individuals with pre-diabetes and early-stage type 2 diabetes. Popp, CJ., St-Jules, DE., Hu, L., et al.[2022]

Medical nutrition therapy (MNT) has been shown to effectively improve glycemic control and help maintain a healthy weight in individuals with type 2 diabetes, as demonstrated in two case studies.

The combination of a personalized diet and coaching support from certified experts can significantly reduce cardiovascular risk factors, highlighting the importance of tailored nutrition programs in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. Unverdorben, S.[2023]

High-quality diets and healthy lifestyles are crucial for managing type 2 diabetes mellitus (T2DM), but there is no consensus on the ideal macronutrient proportions for those with pre-diabetes or T2DM.

Personalized dietary approaches, such as coupling Mediterranean diets with genetic information, can lead to improved glycemic control, as demonstrated by a case study of a T2DM patient who achieved rapid results with this tailored diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetically Guided Mediterranean Diet for the Personalized Nutritional Management of Type 2 Diabetes Mellitus. Gkouskou, K., Lazou, E., Skoufas, E., et al.[2021]

In a study involving 225 adults with prediabetes, a personalized postprandial-targeting (PPT) diet led to significantly greater improvements in glycemic control compared to a Mediterranean (MED) diet, as evidenced by a larger reduction in daily time spent with glucose levels above 140 mg/dL and lower HbA1c levels after 6 months.

Both diets were effective in reducing glucose levels, but the PPT diet showed a mean reduction of 1.3 hours per day above 140 mg/dL and a decrease in HbA1c of 0.16%, compared to 0.3 hours and 0.08% for the MED diet, with these benefits maintained at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. Ben-Yacov, O., Godneva, A., Rein, M., et al.[2022]

In a 6-month clinical trial involving 269 adults with obesity and abnormal glucose metabolism, a personalized diet based on individual postprandial glycemic responses did not lead to significantly greater weight loss compared to a standardized low-fat diet.

While both diets resulted in weight loss, the standardized low-fat diet group experienced a greater increase in resting energy expenditure, suggesting that traditional dietary approaches may still be effective for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Personalized Diet to Reduce Postprandial Glycemic Response vs a Low-fat Diet on Weight Loss in Adults With Abnormal Glucose Metabolism and Obesity: A Randomized Clinical Trial. Popp, CJ., Hu, L., Kharmats, AY., et al.[2022]

Postprandial glucose responses (PPGR) are influenced not only by dietary factors but also by genetics, body composition, and gut microbiota, highlighting the complexity of managing blood sugar levels.

Advancements in continuous glucose monitoring and machine learning allow for personalized dietary recommendations that can effectively prevent elevated PPGRs, paving the way for individualized nutrition strategies to combat metabolic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Approach to Personalized Nutrition: Postprandial Glycemic Response and its Relationship to Gut Microbiota. Guizar-Heredia, R., Noriega, LG., Rivera, AL., et al.[2023]

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