75 Participants Needed

Medical Nutrition Therapy for Type 2 Diabetes

(PIHRK'D Trial)

OL
BS
Overseen ByBethany Setser
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Kentucky
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12567

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.15678

Who Is on the Research Team?

BS

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?
1Treatment groups
Experimental Treatment
Group I: Medical Nutrition TherapyExperimental Treatment1 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

Find a Clinic Near You

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.
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.
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.
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]

Citations

Diets do not fail: the success of medical nutrition therapy in patients with diabetes. [2022]
Evidence-based medical nutrition therapy for diabetes. [2017]
Menu selection, glycaemic control and satisfaction with standard and patient-controlled consistent carbohydrate meal plans in hospitalised patients with diabetes. [2010]
Evolution of diabetes medical nutrition therapy. [2019]
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]
Implementing the American Diabetes Association's nutrition recommendations. [2008]
Nutrition management of diabetes in acute care. [2015]
Dietary cholesterol and other nutritional considerations in people with diabetes. [2009]
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