Medical Nutrition Therapy for Type 2 Diabetes

(PIHRK'D Trial)

Overseen By Bethany Setser

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Kentucky

Disqualifiers: No consent

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: 11

Duration: 6 months

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how family support can help people with type 2 diabetes improve their nutrition and physical activity. The study aims to determine if family involvement positively impacts health for those living with this condition. Participants and their families will follow a nutrition and exercise plan for six months. Individuals who have had type 2 diabetes and lived in rural Kentucky for at least a year might be a good fit for the trial.

As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance diabetes care and family involvement strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that Medical Nutrition Therapy is safe for individuals with type 2 diabetes?

Research shows that medical nutrition therapy (MNT) is safe and well-tolerated for people with type 2 diabetes. Studies have found that dietitian-guided MNT can improve blood sugar levels, weight, and overall health. These improvements indicate the therapy's effectiveness and safety for participants.

No major reports of negative effects have been linked to MNT, highlighting its safety. The therapy uses food and nutrition as treatment, offering a natural and non-invasive approach. Overall, evidence supports MNT as a safe method for managing type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Medical Nutrition Therapy is unique because it focuses directly on using diet to manage Type 2 Diabetes, rather than relying solely on medications like metformin or insulin. This approach is personalized, aiming to tailor nutrition plans to individual needs, potentially leading to better blood sugar control and overall health. Researchers are excited because this method could empower patients to manage their diabetes more naturally, with fewer side effects, and improve their quality of life by integrating sustainable lifestyle changes.

What evidence suggests that Medical Nutrition Therapy might be an effective treatment for type 2 diabetes?

Research shows that Medical Nutrition Therapy (MNT), which participants in this trial will receive, effectively helps manage type 2 diabetes. Studies have found that people using MNT often achieve better blood sugar control, with a significant drop in A1C levels, which measure long-term blood sugar. Additionally, dietary changes have been linked to improvements in body weight and blood pressure. Collaborating with dietitians in these therapies has improved condition management. Overall, MNT appears to be a helpful way for people to enhance their diabetes management through diet and nutrition. ^{1 3 6 7 8}

Who Is on the Research Team?

Brittany Smalls, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes who live in rural Kentucky and have been residents for at least a year. It's designed to explore how family support can improve nutrition and physical activity habits. Participants must be diagnosed with type 2 diabetes and willing to consent.

Inclusion Criteria

This criterion seems to be missing some context. It's possible that it's asking about the location of the participant, but it's not clear. Can you provide more details or clarify the context of this criterion?

I have been diagnosed with type 2 diabetes.

You have lived in rural Kentucky for at least 1 year.

Exclusion Criteria

Potential participants without consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline data collection including demographics, clinical outcomes, and social network data

1 week

1 visit (in-person)

Treatment

Participants receive a 6-month nutrition and physical activity intervention with monthly medical nutrition therapy sessions

6 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Medical Nutrition Therapy

Trial Overview

The study tests Medical Nutrition Therapy, focusing on the role of family structures in managing health through diet and exercise plans tailored for diabetic patients and their families over six months.

How Is the Trial Designed?

Group I: Medical Nutrition Therapy Experimental Treatment 1 Intervention

Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.

Medical Nutrition Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Medical Nutrition Therapy for:

• Diabetes management
• High blood pressure management
• High cholesterol management
• Weight management
• Obesity management

Approved in European Union as Medical Nutrition Therapy for:

• Nutritional disorders
• Metabolic disorders
• Gastrointestinal disorders
• Cardiovascular diseases

Approved in Canada as Medical Nutrition Therapy for:

• Chronic disease management
• Nutrition-related disorders
• Weight management

Who Is Running the Clinical Trial?

University of Kentucky

Lead Sponsor

Trials

198

Recruited

224,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

Medical nutrition therapy is crucial for managing diabetes, as it has been shown to effectively reduce hemoglobin A1c levels in randomized controlled trials.

Early referral for lifestyle changes, including dietary adjustments and physical activity, can significantly prevent the onset of type 2 diabetes or slow its progression, highlighting the importance of education on glycemic control for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diets do not fail: the success of medical nutrition therapy in patients with diabetes. Kulkarni, K.[2022]

In a 12-week study involving 120 overweight or obese adults with Type 2 Diabetes Mellitus, the group receiving a diabetes-specific nutrition supplement (DSNS) showed a significant reduction in glycosylated hemoglobin (HbA1c) and fasting blood glucose compared to the control group, indicating improved glycemic control.

The intervention group also experienced a greater reduction in postprandial plasma glucose and glycemic excursions, with no serious adverse events reported, suggesting that DSNS can be a safe and effective addition to lifestyle interventions for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study Evaluating the Effects of Diabetes Specific Nutrition Supplement and Lifestyle Intervention on Glycemic Control in Overweight and Obese Asian Indian Adults with Type 2 Diabetes Mellitus. Mohan, V., Kalpana, N., Lakshmipriya, N., et al.[2022]

Eating one or more eggs a day does not negatively affect lipid profiles or cardiovascular disease (CVD) risk in the general population, according to studies like the Harvard Egg Study.

However, for people with diabetes, consuming more than one egg per day is linked to an increased risk of coronary heart disease, indicating a need for further research to understand this association.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary cholesterol and other nutritional considerations in people with diabetes. Lau, DC.[2009]

The primary goals of medical nutrition therapy for diabetes include achieving optimal metabolic outcomes, preventing complications, promoting healthy food choices, and addressing individual nutritional needs.

Moderate caloric restriction combined with increased physical activity is emphasized as an effective strategy for managing diabetes, with carbohydrate counting being a recommended option for all patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing the American Diabetes Association's nutrition recommendations. Leontos, C.[2008]

Medical nutrition therapy (MNT) is an effective approach for managing glycemia, lipids, and blood pressure in individuals with diabetes, as supported by the 2002 American Diabetes Association guidelines.

MNT should evolve from focusing on weight management to improving insulin resistance and metabolic control, especially as beta-cell function declines, necessitating a shift from dietary management alone to combinations with oral medications and insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based medical nutrition therapy for diabetes. Franz, MJ.[2017]

In a study comparing two meal plans for hospitalized diabetes patients, the patient-controlled meal plan led to higher patient satisfaction and more opportunities for nutrition education, but also resulted in a significantly higher frequency of hypoglycemia (3.23% vs 0.39%).

The standard consistent-carbohydrate meal plan was associated with less hypoglycemia and required less oversight from clinicians, suggesting that while both meal plans can be effective, the patient-controlled option may need additional monitoring to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menu selection, glycaemic control and satisfaction with standard and patient-controlled consistent carbohydrate meal plans in hospitalised patients with diabetes. Curll, M., Dinardo, M., Noschese, M., et al.[2010]

Nutrition therapy for hospitalized patients with diabetes should integrate glycemic control into their care plan, emphasizing individualized meal planning based on metabolic needs and a consistent carbohydrate approach to ensure safety and effective management of blood sugar levels.

Collaboration among healthcare teams is crucial for coordinating blood glucose monitoring, insulin administration, and meal timing, along with providing self-management education to prepare patients for safe discharge and ongoing diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition management of diabetes in acute care. Whitham, D.[2015]

Medical nutrition therapy is crucial for achieving diabetes treatment goals, especially for patients on insulin, where integrating the insulin regimen into their lifestyle is a top priority.

For individuals with type 2 diabetes, focusing on lifestyle changes like nutrition and exercise is essential for improving metabolic outcomes, and ongoing education and support from a coordinated healthcare team are vital for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of diabetes medical nutrition therapy. Franz, MJ., Warshaw, H., Daly, AE., et al.[2019]

Citations

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pmc.ncbi.nlm.nih.gov

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Medical nutrition therapy and dietary counseling for ...

Impact of the duration of diabetes and frequency of counseling on the effectiveness of dietitian-led medical nutrition therapy in patients with type 2 diabetes.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12329975/

Effects of 12 nutritional interventions on type 2 diabetes

Numerous trials confirm dietary interventions benefit type 2 diabetes mellitus (T2DM) management, but the optimal model is unclear.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0261561420306683

Effectiveness of dietetic intervention for people with type 2 ...

Nutrition therapy provided by dietitians was associated with better clinical parameters of type 2 diabetes, including clinically significant improved glycaemic ...

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ajcn.nutrition.org

ajcn.nutrition.org/article/S0002-9165(23)66120-9/fulltext

The effectiveness of medical nutrition therapy provided by a ...

In adults with prediabetes, MNT was effective in improving glycemic outcomes, anthropometrics, blood pressure, and most lipid levels. However, ...

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diabetesjournals.org

diabetesjournals.org/spectrum/article/31/1/83/32902/Effect-of-Medical-Nutrition-Therapy-for-Patients

Effect of Medical Nutrition Therapy for Patients With Type 2 ...

It is well documented that MNT can improve glycemic control by reducing A1C and, when used with other components of diabetes care, can further ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1751991819301445

The health effects of medical nutrition therapy by dietitians ...

Patients with diabetes who received medical nutrition therapy showed significant improvements in outcome measures of FBS, HbA1c, weight, BMI, waist ...

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revistaendocrino.org

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Expert consensus on medical nutrition therapy for people ...

Medical nutritional therapy is crucial for managing type. 2 diabetes; this consensus provides practical, evidence- based action points. ▫ A ...

8.

jandonline.org

jandonline.org/article/S2212-2672(17)31849-X/fulltext

The Role of Medical Nutrition Therapy and Registered ...

MNT provided by RDNs is also successful and essential to preventing progression of prediabetes and obesity to type 2 diabetes. It is essential that MNT provided ...