What side effects are associated with this type of intervention?

Common treatments for Type 2 Diabetes include lifestyle modifications, oral glucose-lowering drugs, and insulin. Lifestyle modifications, such as diet and exercise, can lead to weight loss and improved glycemic control but may be difficult to maintain long-term. Oral glucose-lowering drugs, like metformin, can cause gastrointestinal issues such as nausea and diarrhea. Insulin therapy can lead to weight gain and hypoglycemia. Nutritional support, such as meal replacements or food vouchers, aims to improve glycemic control but may require careful planning to ensure balanced nutrition and adherence.

What prior FDA approvals exist?

The FDA has approved several classes of drugs for the treatment of Type 2 Diabetes, including metformin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, and GLP-1 receptor agonists. These medications help manage blood glucose levels through various mechanisms, such as increasing insulin sensitivity, enhancing insulin secretion, or reducing glucose reabsorption in the kidneys. While the trial on Mailed Stock Boxes and Food Vouchers focuses on nutritional support, it complements the pharmacologic approach by addressing dietary needs, which is crucial for effective diabetes management. Notably, GLP-1 receptor agonists like liraglutide and exenatide have shown benefits in glycemic control and weight management, aligning with the holistic approach of combining medication with lifestyle and dietary interventions.

What other types of research exist?

Promising alternatives to mailed stock boxes and food vouchers for nutritional support in T2D patients include: 1) Personalized medical nutrition therapy, which tailors dietary plans based on individual metabolic responses and preferences. 2) Use of advanced pharmacological agents such as GLP-1 receptor agonists and SGLT-2 inhibitors, which not only improve glycemic control but also offer cardiovascular benefits. 3) Implementation of digital health tools and mobile apps for continuous glucose monitoring and dietary tracking, providing real-time feedback and support. 4) Incorporation of plant-based or low-carbohydrate diets, which have been shown to improve glycemic control and reduce cardiometabolic risk factors.

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Diabetes Education + Food Assistance for Type 2 Diabetes (LIFT-DM Trial)

N/A

Waitlist Available

Led By Leonard E Egede, MD

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months post randomization

Awards & highlights

Summary

This trial is testing different ways to help low-income African Americans with Type 2 Diabetes manage their blood sugar. It combines diabetes education with either food vouchers, mailed food boxes, or both. The goal is to see if these methods improve blood sugar control better than education alone.

Who is the study for?

This trial is for African American adults with Type 2 Diabetes who are experiencing food insecurity, have an income at or below 133% of the federal poverty level or are Medicaid eligible, and can communicate in English. Participants must be over 21 years old with a clinical diagnosis of diabetes and HbA1c levels >=8%. Those with drug/alcohol dependency, short life expectancy, significant dementia, active psychosis, or involvement in other diabetes trials cannot join.

What is being tested?

The LIFT-DM study is testing whether monthly mailed stock boxes of food or monthly food vouchers improve blood sugar control better than just diabetes education alone. It's also checking if combining both stock boxes and vouchers has a superior effect. Participants will be randomly assigned to one of four groups: only education; education plus stock boxes; education plus vouchers; or all three combined.

What are the potential side effects?

Since this trial involves non-medical interventions like food assistance and educational support rather than drugs or medical procedures, there aren't typical side effects as seen in pharmaceutical trials. However, participants may experience changes in diet habits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycemic control (HbA1c)

Secondary study objectives

Blood Pressure

LDL-Cholesterol

Quality of Life as measured by the SF-12

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group 4 -- Diabetes Education Plus Combination of Monthly FoodExperimental Treatment1 Intervention

Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.

Group II: Group 3 - Diabetes Education Plus Monthly Stock BoxesExperimental Treatment1 Intervention

Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.

Group III: Group 2 - Diabetes Education Plus Monthly Food VouchersExperimental Treatment1 Intervention

Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.

Group IV: Group 1- Diabetes Education OnlyActive Control1 Intervention

Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Type 2 Diabetes include lifestyle modifications, oral hypoglycemic agents, and insulin therapy. Lifestyle modifications, such as diet and exercise, improve insulin sensitivity and promote weight loss, which is crucial for glycemic control. Oral hypoglycemic agents like metformin reduce hepatic glucose production and increase insulin sensitivity, while sulfonylureas stimulate insulin secretion from pancreatic beta cells. Insulin therapy directly supplements insulin levels to manage blood glucose. Nutritional support, as studied in the trial with mailed stock boxes and food vouchers, is essential because it ensures consistent access to healthy foods, aiding in weight management and glycemic control, which are foundational to managing Type 2 Diabetes.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.Assessing the impact of a new delivery method of insulin on glycemic control using a novel trial design.Overcoming obstacles in risk factor management in type 2 diabetes mellitus.

Find a Location

Who is running the clinical trial?

State University of New York at BuffaloLead Sponsor

264 Previous Clinical Trials

51,800 Total Patients Enrolled

Medical College of WisconsinLead Sponsor

620 Previous Clinical Trials

1,172,274 Total Patients Enrolled

Leonard E Egede, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes Clinical Trial Eligibility Overview. Trial Name: NCT04181424 — N/A

Type 2 Diabetes Research Study Groups: Group 1- Diabetes Education Only, Group 3 - Diabetes Education Plus Monthly Stock Boxes, Group 2 - Diabetes Education Plus Monthly Food Vouchers, Group 4 -- Diabetes Education Plus Combination of Monthly Food

Type 2 Diabetes Clinical Trial 2023: Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes Highlights & Side Effects. Trial Name: NCT04181424 — N/A

Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes 2023 Treatment Timeline for Medical Study. Trial Name: NCT04181424 — N/A

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