Clinical Research Directory

Medically Tailored Meals for Cardiovascular Health

This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are: 1. Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients and fresh produce, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs? 2. Is the MTM program coupled with the cardiovascular health curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs? To answer question 1, 66 participants with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum. To answer question 2, 110 participants with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs (due to not having advanced disease with complications) will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum. All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months.

IMPACT OF DIABETES HEALTHCARE PROGRAM ON GLYCEMIC CONTROL AND SELF-EFFICACY AMONG TYPE-II DIABETICS IN ISLAMABAD PAKISTAN

Type 2 Diabetes Mellitus (T2DM) is a significant public health challenge in Pakistan, characterized by a growing prevalence and substantial economic burden. The alarming rise in T2DM cases in Pakistan highlights the need for evidence-based solutions to control the disease. However, there is a notable knowledge gap in the effectiveness of diabetes healthcare program interventions in Pakistan. The goal of this randomized controlled trial (RCT) is to evaluate the effectiveness of a Diabetes Healthcare Program in improving glycemic control and enhancing Self-efficacy and diabetes knowledge in Type-II Diabetic patients in Islamabad, Pakistan. The main questions it aims to answer are whether the Diabetes Healthcare Program can reduce HbA1c levels and enhance Self-efficacy and diabetes knowledge in Type-II Diabetic patients. Researchers will compare the outcomes of 65 patients receiving the Diabetes Healthcare Program with 65 patients receiving standard care to see if the program improves glycemic control and enhances Self-efficacy and diabetes knowledge. Participants will attend 12 weeks of Diabetes Healthcare Program sessions, receive standard care from the hospital's diabetes department, and complete surveys and questionnaires to assess their Self-efficacy and glycemic control at baseline and after the 3 months intervention period.

Effect of a Structured Educational Intervention Through Mobile App on Hemoglobin A1c (HbA1c), Self-Efficacy and Self- Care in Adolescent With Type 1 Diabetes (T1DM)

This study aims to evaluate the effectiveness of a mobile health (mHealth) educational intervention for adolescents with Type 1 Diabetes Mellitus (T1DM). Adolescents often face challenges in maintaining optimal blood glucose control and performing regular self-care. In this study, participants will receive structured diabetes education through a mobile application designed to improve their knowledge, self-efficacy (SE), and self-management skills. The impact of the intervention will be assessed by measuring changes in HbA1c levels, diabetes self-efficacy, and self-care (SC)behaviors over time. These findings may help determine whether mobile app-based education can support better diabetes management among adolescents.

The Influence of Anemia on HbA1c Readings in Non-Diabetic Patients

The goal of this observational study is to learn about the effects of different types of anemia on HbA1c test results in non-diabetic adults who have anemia but do not have diabetes. The main question it aims to answer is: \- Do different types of anemia (iron deficiency, vitamin B12/folate deficiency, thalassemia, and anemia of chronic illness) cause HbA1c levels to be falsely high or low in people without diabetes?

Phase-III Clinical Studies on Poly Herbal Anti-Diabetic Formulation

The goal of this clinical trial to learn the clinical efficacy and safety of standardized polyherbal capsule weighing around 500 mg, containing Syzygium cumini, Momordica charantia, Wrightia tinctoria, and Gymnema sylvestre in equal proportions for controlling Diabetic hyperglycemia towards a normal glycemic control. The main question that aims to search is 1. Does the herbal combination formula effective to lower the high blood glucose levels in Type2 diabetics 2. Is the herbal combination therapy is safe for human use 3. Does this treatment plan reduces the blood sugar level comparative to Metformin 500 mg TID The trial is also comparing its efficacy in comparison to a standard anti diabetic drug Metformin In the study wing, the volunteer diabetic patients will take the herbal capsule 500mg TID and in the control group the volunteer patients will take Metformin 500 mg TID. * The recruited patients will continue the assigned therapy for at least six months * They visit the clinical trial OPDs fortnightly * They will record their fasting blood glucose with the glucometer at least two to three times a week and get the basal tests done in three-month time

Pulses: Optimizing Pulse Consumption for Cardiometabolic Health

This randomized clinical trial aims to evaluate the effects of consuming two different doses of pulses (1.5 cups/week or 3 cups/week) in individuals with baseline intake below 1.5 cups/week, compared to a control group receiving standard nutrition education based on the United States Department of Agriculture's (USDA) My Plate guidelines. The main question the Pulses study aims to answer is: • What is the effect of increasing pulse consumption (in a dose-response manner) on specific cardiometabolic risk factors, including LDL-C, CRP, HBA1C, and blood pressure compared to standard nutrition education? For secondary outcomes, this study aims to answer the following: • Does increased pulse consumption improve the following: overall serum lipid profile (Total cholesterol (TC), HDL-C, Triglycerides (TG), diet quality (measured by the Healthy Eating Index), and participants self-reported satisfaction with life (SWLS) and Satisfaction with Food-related Life (SWFoL). All participants will attend biweekly classes and food demonstrations. The pulses groups will learn to prepare various pulse-based recipes, while the control group will receive guidance on preparing healthy meals following the USDA MyPlate recommendations.

The Effects of Jing-Si Herbal Tea Liquid Packets and Jing-Si Herbal Tang Heng Power Drink

Through empirical research evaluating the effects of "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" as adjunctive treatments for various cardiovascular diseases, we aim to provide sufficient evidence to address the following questions: 1. Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" significantly improve various inflammatory responses involved in the process of atherosclerosis, thereby enhancing the prognosis of patients with acute coronary syndrome and chronic ischemic heart disease? 2. Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" provide a healthy and effective adjunctive therapy for patients with hypertension, diabetes, and hyperlipidemia by lowering blood pressure (potentially related to known ACE2 receptors), blood glucose levels (including the improvement of pancreatic β-cell insulin secretion capacity and cellular insulin utilization efficiency), and cholesterol levels? 3. Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" influence the prognosis of various diseases, including the most critical cardiovascular conditions such as acute coronary syndrome and chronic ischemic heart disease, by altering the human gut microbiota? 4. Can "JING SI HERBAL TEA LIQUID PACKETS" and "JING SI HERBAL TANG HENG POWDER DRINK" improve renal indicators such as BUN, creatinine, UACR, and eGFR, thereby protecting the kidneys and reducing complications like microalbuminuria?

Daily Protein Pacing Effects on HbA1c in Type 2 Diabetics

This study will examine the effects of protein (whey) supplementation added to the normal diet of pre-diabetes or diagnosed type 2 diabetes mellitus (T2DM) men and women on plasma glycated hemoglobin (HbA1c) and total body fat levels. Specifically, this study will directly quantify the impact of 3x/day timed ingestion of supplemental whey protein (20 grams of 80 calories per serving) added to the normal diet of free-living pre-diabetic or T2DM men and women over an 8-week study period on the major diagnostic outcome of pre-diabetic and T2DM (HbA1c levels) and total body fat levels. This study will quantify changes in HbA1C and total body fat levels in 24 pre-diabetics or T2DM participants.