Personalized Dietary Management for Type 2 Diabetes

(DiaTeleMed Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Collin J Popp, PhD, RD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Trial Summary

What is the purpose of this trial?

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). In the first phase, participants will be randomized with equal allocation to these 3 groups. In the second phase (current phase), the remaining participants will be randomized with equal allocation to the Standardized and UCC groups.

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.

What data supports the effectiveness of the treatment Personalized Dietary Management for Type 2 Diabetes?

Research suggests that personalized dietary approaches, such as those using a machine-learning algorithm to predict glycemic response, can improve glycemic control in individuals with type 2 diabetes. Additionally, combining Mediterranean diets with genetic information has shown promise in achieving better glycemic control, as evidenced by a case study of a patient with type 2 diabetes. ^{1 2 3 4 5}

Is personalized dietary management for type 2 diabetes safe for humans?

The research does not specifically address safety concerns, but personalized dietary management approaches, like the Mediterranean diet and personalized postprandial glucose response-targeting diets, are generally considered safe and focus on improving metabolic health and glycemic control. ^{1 2 4 6 7}

How is the Personalized Dietary Management for Type 2 Diabetes treatment different from other treatments?

This treatment is unique because it combines a Mediterranean diet with personalized guidance to minimize blood sugar spikes after meals, using a gut microbiome-based algorithm and behavioral counseling. This personalized approach aims to improve blood sugar control by tailoring dietary advice to individual responses, unlike standard one-size-fits-all dietary recommendations. ^{1 2 4 5 8}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

National Institute of Nursing Research (NINR) Collaborator

References

1. United States 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. [2022] Weight loss reduces the risk of type 2 diabetes mellitus (T2D) in overweight and obese individuals. Although the physiological response to food varies among individuals, standard dietary interventions use a "one-size-fits-all" approach. The Personal Diet Study aims to evaluate two dietary interventions targeting weight loss in people with prediabetes and T2D: (1) a low-fat diet, and (2) a personalized diet using a machine-learning algorithm that predicts glycemic response to meals. Changes in body weight, body composition, and resting energy expenditure will be compared over a 6-month intervention period and a subsequent 6-month observation period intended to assess maintenance effects. The behavioral intervention is delivered via mobile health technology using the Social Cognitive Theory. Here, we describe the design, interventions, and methods used.

2. Switzerland pubmed.ncbi.nlm.nih.gov

Genetically Guided Mediterranean Diet for the Personalized Nutritional Management of Type 2 Diabetes Mellitus. [2021] The current consensus for the prevention and management of type 2 diabetes mellitus (T2DM) is that high-quality diets and adherence to a healthy lifestyle provide significant health benefits. Remarkably, however, there is little agreement on the proportions of macronutrients in the diet that should be recommended to people suffering from pre-diabetes or T2DM. We herein discuss emerging evidence that underscores the importance of gene-diet interactions in the improvement of glycemic biomarkers in T2DM. We propose that we can achieve better glycemic control in T2DM patients by coupling Mediterranean diets to genetic information as a predictor for optimal diet macronutrient composition in a personalized manner. We provide evidence to support this concept by presenting a case study of a T2DM patient who achieved rapid glycemic control when adhered to a personalized, genetically-guided Mediterranean Diet.

3. Netherlands 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. [2022] To investigate the superiority of individualized dietary advice based on dietary assessment for patients with type 2 diabetes.

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

Personalized Postprandial Glucose Response-Targeting Diet Versus Mediterranean Diet for Glycemic Control in Prediabetes. [2022] To compare the clinical effects of a personalized postprandial-targeting (PPT) diet versus a Mediterranean (MED) diet on glycemic control and metabolic health in prediabetes.

5. England 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. [2022] Dietary modifications are crucial for managing newly diagnosed type 2 diabetes mellitus (T2DM) and preventing its health complications, but many patients fail to achieve clinical goals with diet alone. We sought to evaluate the clinical effects of a personalized postprandial-targeting (PPT) diet on glycemic control and metabolic health in individuals with newly diagnosed T2DM as compared to the commonly recommended Mediterranean-style (MED) diet.

6. United States 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. [2022] Interindividual variability in postprandial glycemic response (PPGR) to the same foods may explain why low glycemic index or load and low-carbohydrate diet interventions have mixed weight loss outcomes. A precision nutrition approach that estimates personalized PPGR to specific foods may be more efficacious for weight loss.

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

A New Approach to Personalized Nutrition: Postprandial Glycemic Response and its Relationship to Gut Microbiota. [2023] A prolonged and elevated postprandial glucose response (PPGR) is now considered a main factor contributing for the development of metabolic syndrome and type 2 diabetes, which could be prevented by dietary interventions. However, dietary recommendations to prevent alterations in PPGR have not always been successful. New evidence has supported that PPGR is not only dependent of dietary factors like the content of carbohydrates, or the glycemic index of the foods, but is also dependent on genetics, body composition, gut microbiota, among others. In recent years, continuous glucose monitoring has made it possible to establish predictions on the effect of different dietary foods on PPGRs through machine learning methods, which use algorithms that integrate genetic, biochemical, physiological and gut microbiota variables for identifying associations between them and clinical variables with aim of personalize dietary recommendations. This has allowed to improve the concept of personalized nutrition, since it is now possible to recommend through these predictions specific dietary foods to prevent elevated PPGRs that are highly variable among individuals. Additional components that can enrich the predictive algorithms are findings of nutrigenomics, nutrigenetics and metabolomics. Thus, this review aims to summarize the evidence of the components that integrate personalized nutrition focused on the prevention of PPGRs, and to show the future of personalized nutrition by laying the groundwork for the development of individualized dietary management and its impact on the improvement of metabolic diseases.

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

The Meaningful Effects of a Personalized Nutrition and Coaching Program for Type 2 Diabetes Mellitus: Two Case Reports. [2023] Type 2 Diabetes (T2DM) is a global health crisis affecting 10.5% adults worldwide. The numbers are even higher in the United States with currently 11.3% of all Americans diagnosed with T2DM. Research has confirmed that medical nutrition therapy (MNT) including a customized diet and coaching support can be an effective tool for diabetes care. In this report we describe two cases in which MNT improved glycemic control, helped to reach, and maintain a healthy weight, and reduced critical cardiovascular risk factors. This report shows that a personalized nutrition program combined with coaching by certified experts can be an effective tool in the daily diabetes practice.