Clinical Trials Logo
  1. Home
  2. Type 2 Diabetes
  3. NCT04523155
  4. Details
NCT04523155 Clinical Trial

Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes

Type 2 Diabetes Clinical Trial

Official title:
Effect of Medically-tailored Meal Delivery Service on Changes in Hemoglobin A1c (HbA1c) in Patients With Diabetes: A Randomized, Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04523155
Other study ID # 20-004608
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 24, 2020
Est. completion date June 4, 2021

Study information
Verified date July 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of medically-tailored meal delivery (10 meals per week for 3 months) on glycemic control in diabetic patients.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date June 4, 2021
Est. primary completion date June 4, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility Inclusion Criteria: - Adult men and women with non-insulin dependent diabetes. - Ages 25 to 75 years. - Fasting blood sugar of greater than 140 mg/dl, on no oral hypoglycemic agents and a hemoglobin A1C less than 13%. - Stabilized patients on oral hypoglycemic agents for one month or longer prior to starting the study and a hemoglobin A1C between 7.5% - 13%. Exclusion Criteria: - Insulin use. - Substance abuse. - Any documented medical problem that would inhibit full participation in the study. - BMI less than 25 or great than 40. - Vegans or Vegetarians - Individuals with food allergies. - Individuals currently on a commercial weight loss or diet program.

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Medically tailored meals
10 meals per week for 3 months

Locations
Country Name City State
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic in Florida Jacksonville Florida

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Glucose Metabolism Measured by HbA1c levels in standard chemistry in blood Baseline, 3 monts
Secondary Change in Weight Measured in killograms Baseline, 3 months
Secondary Change in Blood Pressure Measured in units of millimeters of mercury (mmHg) Baseline, 3 months
Secondary Change in High Density lipoprotein (HDL) HDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) Baseline, 3 months
Secondary Change in Low Density Lipoprotein (LDL) LDL cholesterol levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) Baseline, 3 months
Secondary Change in Triglycerides Triglyceride levels measured by standard chemistry in blood reported in units of milligrams per deciliter (mg/dL) Baseline, 3 months
See also
  Status Clinical Trial Phase
Completed NCT05219994 - Targeting the Carotid Bodies to Reduce Disease Risk Along the Diabetes Continuum N/A
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Completed NCT02284893 - Study to Evaluate the Efficacy and Safety of Saxagliptin Co-administered With Dapagliflozin in Combination With Metformin Compared to Sitagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Metformin Therapy Alone Phase 3
Completed NCT04274660 - Evaluation of Diabetes and WELLbeing Programme N/A
Active, not recruiting NCT05887817 - Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) Phase 4
Active, not recruiting NCT05566847 - Overcoming Therapeutic Inertia Among Adults Recently Diagnosed With Type 2 Diabetes N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Completed NCT04965506 - A Study of IBI362 in Chinese Patients With Type 2 Diabetes Phase 2
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Active, not recruiting NCT03982381 - SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes Phase 4
Completed NCT04971317 - The Influence of Simple, Low-Cost Chemistry Intervention Videos: A Randomized Trial of Children's Preferences for Sugar-Sweetened Beverages N/A
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Completed NCT04023539 - Effect of Cinnamomum Zeylanicum on Glycemic Levels of Adult Patients With Type 2 Diabetes N/A
Recruiting NCT05572814 - Transform: Teaching, Technology, and Teams N/A
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Completed NCT04097600 - A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets Phase 1
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Completed NCT05378282 - Identification of Diabetic Nephropathy Biomarkers Through Transcriptomics
Active, not recruiting NCT06010004 - A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Phase 3
Completed NCT03653091 - Safety & Effectiveness of Duodenal Mucosal Resurfacing (DMR) Using the Revita™ System in Treatment of Type 2 Diabetes N/A

External Links