Medical Nutrition Therapy for Type 2 Diabetes

(PIHRK'D Trial)

Overseen by Brittany Smalls, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kentucky

Disqualifiers: No consent

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this feasibility study is to use family units as support to promote nutrition and physical activity of individuals with type 2 diabetes. The main question it aims to answer is: • How does the family structure impact the health of its members living with type 2 diabetes? Participants will be asked to; * Tell us about their access to food sources and places in the community to engage in physical activity. * A nutrition and physical activity plan will be developed for participants and their families to use for 6 months.

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 data supports the effectiveness of the treatment Medical Nutrition Therapy for Type 2 Diabetes?

Research shows that Medical Nutrition Therapy (MNT) is effective in managing diabetes by helping control blood sugar, cholesterol, and blood pressure. It involves creating a meal plan that fits into a person's lifestyle, which can improve overall health and help manage diabetes better. ^{1 2 3 4 5}

Is Medical Nutrition Therapy safe for humans?

Medical Nutrition Therapy, which includes nutrition counseling and dietary therapy, is generally considered safe for humans. It focuses on healthy eating and lifestyle changes, which are beneficial for managing diabetes and other health conditions. ^{2 5 6 7 8}

How is Medical Nutrition Therapy different from other treatments for Type 2 Diabetes?

Medical Nutrition Therapy (MNT) is unique because it focuses on personalized dietary changes and lifestyle interventions to manage blood sugar levels, rather than relying solely on medication. It involves creating a meal plan that fits into a person's lifestyle and can be used alongside other treatments like insulin or oral medications to improve overall metabolic control. ^{1 2 3 5 6}

Research Team

Brittany Smalls, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

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

Trial Timeline

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)

Treatment Details

Interventions

• Medical Nutrition Therapy (Behavioral Intervention)

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.

Participant Groups

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 Canada for the following indications:

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+

Dr. William T. Abraham

University of Kentucky

Chief Medical Officer since 2019

MD, University of Kentucky

Dr. Kenneth Cundy

University of Kentucky

Chief Executive Officer

PhD in Pharmaceutical Sciences from the University of Kentucky

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Charles D. Henderson

American Diabetes Association

Chief Executive Officer since 2020

Bachelor's degree from Texas A&M University

Osagie Ebekozien

American Diabetes Association

Chief Medical Officer since 2024

MD, MPH, CPHQ

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

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

3. England 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. [2010]

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

Evolution of diabetes medical nutrition therapy. [2019]

5. India 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. [2022]

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

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

7. Canada pubmed.ncbi.nlm.nih.gov

Nutrition management of diabetes in acute care. [2015]

8. England pubmed.ncbi.nlm.nih.gov

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