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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different nutrition approaches can help African American women with type 2 diabetes avoid or manage complications. Two groups will participate: one will receive diabetes-focused nutrition therapy (Medical Nutrition Therapy for Diabetes), while the other will receive the same therapy with added motivational support (Motivational Interviewing) to assist with lifestyle changes. Participants will attend group sessions with trained nutritionists, followed by a maintenance phase and then a no-contact period. Women who have had type 2 diabetes for at least six months and are at risk for further health issues, such as high blood sugar or high blood pressure, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding effective nutrition strategies for managing diabetes.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Medical Nutrition Therapy (MNT) for type 2 diabetes is safe and well-tolerated by patients. In studies with adults who have type 2 diabetes, MNT helped manage blood sugar levels without causing significant side effects. Specifically, 21 studies reported that MNT reduced HbA1c levels (a measure of blood sugar control) by 0.3% to 2.0% after three months, indicating that MNT can improve health without causing harm.

Motivational Interviewing (MI), another method under study, is also considered safe. Research has shown that patients experienced improvements in A1C levels, which measure long-term blood sugar control, without major side effects. While the effectiveness of MI can vary, it remains consistently safe.

Overall, both MNT and MI have been used to manage type 2 diabetes with minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Medical Nutrition Therapy (MNT) for Type 2 Diabetes because it offers a personalized dietary approach that could enhance diabetes management in a way that standard medications, like metformin or insulin, might not. Unlike traditional treatments that primarily focus on lowering blood sugar through medication, MNT emphasizes a group-based dietary intervention that educates and motivates patients to make lasting lifestyle changes. The addition of motivational interviewing (MI) in one arm of the study further distinguishes this approach by providing psychological support to boost patients' commitment to healthier eating habits. This holistic focus on both nutrition and motivation could potentially improve patient outcomes by addressing both the physiological and behavioral aspects of diabetes management.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

Research has shown that Medical Nutrition Therapy (MNT), one of the treatments in this trial, can significantly improve health for people with type 2 diabetes. Studies have found that MNT can lower A1C levels by up to 2%, leading to better blood sugar control. It also helps reduce fasting blood sugar levels, blood pressure, and cholesterol.

In this trial, some participants will receive MNT alone, while others will receive MNT combined with Motivational Interviewing (MI). MI enhances the effectiveness of MNT by encouraging behavior changes that improve blood sugar management and mental health. Studies indicate that MI can lower glycated hemoglobin (a measure of long-term blood sugar control) and boost emotional well-being. Together, MNT and MI offer a robust approach for managing type 2 diabetes. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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) 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5813315/

Effect of Medical Nutrition Therapy for Patients With Type 2 ... This study evaluated the contribution of MNT in improving A1C and blood pressure in a population of low-income adults with type 2 diabetes.

2. nutritionandmetabolism.biomedcentral.com nutritionandmetabolism.biomedcentral.com/articles/10.1186/s12986-025-00968-3

Effects of 12 nutritional interventions on type 2 diabetes MNT was the most effective for reducing FPG, while LGI dietary intervention was the preferred choice for reducing 2hPG and HOMA-IR. Digital ...

3. diabetesjournals.org diabetesjournals.org/care/article/42/5/731/40480/Nutrition-Therapy-for-Adults-With-Diabetes-or

Nutrition Therapy for Adults With Diabetes or Prediabetes Strong evidence supports the effectiveness of MNT interventions provided by RDNs for improving A1C, with absolute decreases up to 2.0% (in type ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523661209

The effectiveness of medical nutrition therapy provided by ... In adults with prediabetes, MNT was effective in improving glycemic outcomes, anthropometrics, blood pressure, and most lipid levels.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6824451/

Insights on Medical Nutrition Therapy for Type 2 Diabetes ... MNT plays an integral role in decelerating the conversion of prediabetes to diabetes and is a cost-effective measure in improving outcomes and quality of life ...

6. revistaendocrino.org revistaendocrino.org/index.php/rcedm/article/download/929/1301/6491

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 ...

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

The Role of Medical Nutrition Therapy and Registered ... In adults with type 2 diabetes, 21 study arms in 18 studies reported that MNT significantly lowered HbA1c by 0.3% to 2.0% at 3 months, and with ongoing MNT ...