Medical Nutrition Therapy for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Stephania Miller-Hughes, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Meharry Medical College

Disqualifiers: Psychotic disorders

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

Compensation: Varies

Number of Visits: 7

291 Participants Needed

Trial Summary

What is the purpose of this trial?

A two-arm randomized controlled trial design will be used. Participants will include 291 African American women with type 2 diabetes that are at risk for development and/or progression of diabetes complications. Both arms, diabetes medical nutrition therapy (MNT) and diabetes MNT plus motivational interviewing (MI), will include: 1) a 3-month active intervention period of six biweekly (every other week), group-based, trained nutritionist-facilitated sessions; 2) a 3-month maintenance intervention period, which will include one group-based maintenance support session; and 3) a 6-month inactive period (no contact). The differences between arms is the integration of culturally-adapted MI exercises during the diabetes MNT plus MI active and maintenance intervention periods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

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

Research shows that Medical Nutrition Therapy (MNT) is crucial for managing type 2 diabetes, helping to improve blood sugar control and beta-cell function, which are important for insulin production. MNT is personalized to fit each patient's lifestyle and dietary habits, making it an effective part of diabetes treatment. ^{1 2 3 4 5}

Is Medical Nutrition Therapy safe for humans?

Medical Nutrition Therapy (MNT) is generally considered safe for humans, as it involves personalized dietary plans to help manage conditions like type 2 diabetes. It is a key part of diabetes treatment and is used alongside other therapies to improve health outcomes. ^{1 2 3 4 5}

How is Medical Nutrition Therapy different from other treatments for type 2 diabetes?

Medical Nutrition Therapy (MNT) is unique because it is personalized to each individual's lifestyle and dietary habits, and it works alongside other diabetes treatments to help manage blood sugar levels. Unlike standard drug treatments, MNT involves adjusting meal timing and composition to fit the patient's specific needs and medication schedule. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for African American women with type 2 diabetes, diagnosed at least 6 months ago and at risk of complications (high HbA1c, blood pressure, cholesterol or BMI). It's not suitable for those with psychotic disorders.

Inclusion Criteria

None (This is not a valid exclusion criterion)

I have been diagnosed with type 2 diabetes for over 6 months.

My HbA1c is 7.0% or higher, and I have high blood pressure, cholesterol, or BMI.

Exclusion Criteria

You have been diagnosed with a mental illness that causes psychosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Active Intervention

Participants receive diabetes medical nutrition therapy (MNT) or MNT plus motivational interviewing (MI) in six biweekly group-based sessions

12 weeks

6 visits (in-person)

Maintenance Intervention

Participants attend one group-based maintenance support session

12 weeks

1 visit (in-person)

Inactive Period

No contact period to observe long-term effects without intervention

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diabetes MNT
• Motivational Interviewing

Trial Overview The study tests two approaches: standard diabetes medical nutrition therapy (MNT) and MNT combined with motivational interviewing. Both involve group sessions led by a trained nutritionist over a period of up to 9 months.

Participant Groups

Group I: Diabetes MNT Active Control 1 Intervention

-Group-based dietary intervention

Group II: Diabetes MNT plus MI Active Control 2 Interventions

--Group-based dietary/dietary motivation intervention

Who Is Running the Clinical Trial?

Meharry Medical College

Lead Sponsor

Trials

19

Recruited

6,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Matthew Walker Comprehensive Health Center

Collaborator

Trials

3

Recruited

1,300+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Findings from Research

Medical nutritional therapy (MNT) with reduced carbohydrate content (MNT M-ADA) significantly improved glycemic control in patients with Type 2 Diabetes Mellitus (T2DM) over 24 weeks, as indicated by better HbA1c and self-measured glucose levels without increasing hypoglycemia risk.

The effectiveness of MNT M-ADA was consistent regardless of whether patients were using human or analog premix insulin, highlighting the importance of individualized dietary management in diabetes treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Medical Nutritional Therapy on the Efficacy of Premix Insulin in Glycemic Control in Patients with Type 2 Diabetes. Husaric, S., Salihovic, AA., Kadric, N., et al.[2023]

Medical nutrition therapy (MNT) is crucial for effectively managing type 2 diabetes, emphasizing the importance of collaboration between patients and healthcare teams to set achievable dietary goals.

As type 2 diabetes is a lifelong condition, MNT goals should be regularly assessed and adjusted based on the patient's evolving health and circumstances, highlighting the need for ongoing education about nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical nutrition therapy in type 2 diabetes. Rezabek, KM.[2017]

Medical nutrition therapy (MNT) is crucial for hospitalized patients with diabetes to achieve glycemic control, but it requires individualization and coordination among healthcare teams due to unique hospital challenges.

The consistent carbohydrate meal-planning system is recommended as it focuses on managing carbohydrate intake, which is the main dietary factor affecting blood glucose levels, and necessitates collaboration between nursing and nutrition services for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition therapy for the hospitalized patient with diabetes. Swift, CS., Boucher, JL.[2021]

Medical Nutrition Therapy (MNT) significantly improved various health markers in 160 Type 2 diabetes patients over 3 months, including reductions in weight, body fat, glucose levels, and inflammation as indicated by hsCRP.

MNT also lowered cardiovascular risk, as evidenced by a significant decrease in the Framingham risk score, while not affecting levels of Pentraxin-3 or triglycerides.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EVALUATION OF THE RELATIONSHIP BETWEEN MEDICAL NUTRITION TREATMENT, PENTRAXIN-3, HSCRP AND BODY COMPOSITION ANALYSIS IN TYPE 2 DIABETIC PATIENTS. Duran, R., Marakoğlu, K., Vatansev, H., et al.[2023]

In a study of 68 patients with newly-diagnosed type 2 diabetes, medical nutrition therapy (MNT) significantly improved glycemic control, as shown by a decrease in HbA1c from 9.6% to 7.2% over about 4 months.

MNT also enhanced beta-cell function, indicated by an increase in the disposition index, while insulin sensitivity was more closely related to weight control rather than directly to glycemic levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of beta-cell function in conjunction with glycemic control after medical nutrition therapy in newly-diagnosed type 2 diabetes mellitus. Takahara, M., Shiraiwa, T., Maeno, Y., et al.[2022]

A systematic review of 12 intervention studies involving adolescents with type 1 diabetes found that the effectiveness of medical nutrition therapy (MNT) on various health outcomes, such as dietary patterns and glycemic control, was inconsistent and often conflicted.

The limited number of high-quality studies and the high risk of bias in existing research highlight the need for more robust clinical trials to better understand the role of MNT in managing type 1 diabetes in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of medical nutrition therapy in adolescents with type 1 diabetes: a systematic review. Granado-Casas, M., Solà, I., Hernández, M., et al.[2022]

References

1. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

The Impact of Medical Nutritional Therapy on the Efficacy of Premix Insulin in Glycemic Control in Patients with Type 2 Diabetes. [2023]

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

Medical nutrition therapy in type 2 diabetes. [2017]

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

Nutrition therapy for the hospitalized patient with diabetes. [2021]

4. Romania pubmed.ncbi.nlm.nih.gov

EVALUATION OF THE RELATIONSHIP BETWEEN MEDICAL NUTRITION TREATMENT, PENTRAXIN-3, HSCRP AND BODY COMPOSITION ANALYSIS IN TYPE 2 DIABETIC PATIENTS. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Improvement of beta-cell function in conjunction with glycemic control after medical nutrition therapy in newly-diagnosed type 2 diabetes mellitus. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of medical nutrition therapy in adolescents with type 1 diabetes: a systematic review. [2022]