Clinical Research Directory

Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management

Day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. This research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.

Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity

This study is a cluster randomized controlled trial with a 2×2 factorial design conducted in community health centers in Kunshan, Wuhan and Shanghai, China. It aims to evaluate the independent and combined effects of exercise and cognitive interventions on intrinsic capacity and related health outcomes among stroke survivors aged 60 years and older with hypertension or type 2 diabetes mellitus. Participants will receive either exercise training, cognitive training, combined training, or usual care over 20 week, followed by a 12\~24 month follow-up. Findings will inform integrated health management strategies for older adults with multimorbidity.

A Study of Enicepatide (CT-388) in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus

This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of enicepatide at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM).

The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes

Type 2 diabetes is a chronic disease with an increasing prevalence worldwide and in our country. In managing type 2 diabetes, the primary goal in the nursing process is to ensure blood glucose stability. In this regard, it is essential to provide individualized nursing interventions and diabetes management education to individuals. The Comprehensive Self-Management of Diabetes Scale can be used to determine individuals' level of diabetes management. Implementing systematic nursing interventions to maintain blood glucose stability and evaluating their impact on nursing outcomes and diabetes management are crucial. Although the NANDA, NIC, and NOC (NNN) system is used for this purpose, research in this area remains limited. There is a need for studies investigating the effects of individualized nursing interventions based on the NNN system on nursing outcomes and comprehensive self-management of diabetes in patients with type 2 diabetes who are at risk of blood glucose variability. This study is planned as a randomized controlled trial with repeated measurements. The topic is original in terms of implementing individualized nursing interventions, providing education, and monitoring patients according to the NNN system to address the risk of blood glucose variability in patients with type 2 diabetes, as well as evaluating its impact on nursing outcomes and comprehensive self-management of diabetes. Another unique aspect of the study is that the effects of the interventions will also be assessed through laboratory results, including fasting blood glucose (FBG), postprandial blood glucose (PBG), HbA1c, height, weight, waist circumference, blood pressure, and pulse measurements. This research aims to improve glycemic control, prevent potential complications of the disease, ensure patient safety, enhance the quality and satisfaction of nursing care, reduce additional treatment costs, and decrease diabetes-related morbidity and mortality. If this study yields positive results, it will contribute to the widespread implementation of individualized nursing interventions using the NNN system to manage blood glucose variability risk, reduce diabetes-related health problems, ensure patient safety, and lower additional treatment costs. Furthermore, it is expected to guide clinical nurses, nurse researchers, and nurse managers in caring for individuals with type 2 diabetes, improve care quality and satisfaction, and support the planning of in-service training programs. From a healthcare institution perspective, it is anticipated to help reduce additional financial burdens and enhance care quality.

Flaxseed Consumption on Biochemical and Quality of Life in Type 2 Diabetes

The main goal of this clinical trial is to determine the effect of flaxseed added to the diet on biochemical parameters and quality of life in patients with Type 2 diabetes mellitus (T2DM). The main questions it aims to answer are: * Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on biochemical parameters? * Does flaxseed supplementation given to T2DM patients for 12 weeks have an effect on quality of life? Researchers will compare patients with T2DM consume diet added flaxseed to a control group to see if flaxseed effect on biochemical parameters and quality of life. Participants will: * Complete the questionnaire, record the 3-day food consumption and be taken the anthropometric measurements at the beginning and end of the study. * Take diet added 30 g ground flaxseed (intervention group) or only diet (control group) every day for 12 weeks. * Visit the clinic once every 4 weeks for follow-up. * Report the dietary adherence and gastrointestinal symptoms on a phone call once every week.

Achieving Routine Intervention and Screening for Emotional Health

The purpose of this project is to evaluate the effectiveness of diabetes distress screening and intervention on patients with type 2 diabetes mellitus (T2DM).

A Study to Evaluate ALN-4324 on Insulin Sensitivity in Adults With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM

A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM

The purpose of this study is to: * evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324 * evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM

The GRoceries Aimed at Increasing Nutrition Study

Only 2% of Americans meet the recommended levels of whole grain consumption, despite its association with reduced risk of type 2 diabetes. This study aims to assess if consumers with prediabetes or type 2 diabetes can be encouraged to switch from buying refined grain products to whole grain products when shopping for groceries online. The study will use personalized marketing strategies, with or without discounts which adjust based on purchasing behavior, to promote whole grain consumption.

Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency

This study aims to evaluate whether dorzagliatin can improve glycemic homeostasis in patients with type 2 diabetes mellitus (T2DM) complicated by chronic renal insufficiency, and to compare the efficacy of dorzagliatin with linagliptin in improving glycemic control in patients with T2DM and moderate to severe chronic renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<45 mL/min/1.73 m²). This is a prospective, randomized, active-controlled, multicenter clinical study planned to enroll 206 eligible patients. After successful screening, patients will enter a 2-week run-in period consisting of diet and exercise control together with continuous glucose monitoring (CGM). Eligible patients will then be randomized to receive dorzagliatin 75 mg twice daily (BID) or linagliptin 5 mg once daily (QD) on top of background antihyperglycemic therapy. Basal insulin therapy will be standardized to insulin glargine U300 after treatment initiation. The treatment period will last 14 weeks, followed by a 1-week safety follow-up period.

A Study of BGM0504 in Participants With Type 2 Diabetes

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

A Study of BGM0504 in Healthy Participants and Participants With Impaired Renal Function

The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCl25 mg/5 mg/1000 mg Extended Release Tablet Versus Trijardy® XR 25 mg/5 mg/1000 mg Extended- Release Tablets

An open label, randomized, two-period, two treatment, two-sequence, crossover, balanced, single dose oral bioequivalence study to compare Empagliflozin/ Linagliptin/ Metformin HCl 25 mg/5 mg/1000 mg Extended Release Tablet versus Trijardy® XR (Empagliflozin/linagliptin/metformin hydrochloride extended-release tablets 25 mg/5 mg/1000 mg) in healthy subject in fast condition.

EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes

This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.

A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes

The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.

Preventing Medication Mismanagement in People Living With Dementia Through Automated Medication Dispensing With Facial Recognition and Video Observation

Globally, \>47M individuals live with dementia, with new incidence of 7.7M annually. Medication mismanagement is one of the most common and concerning risk factors in people with dementia (PwD), as it leads to undertreatment, emergency room visits, hospital admissions/readmissions, and serious adverse events. 3M older U.S. adults are admitted to nursing homes due to drug-related adherence problems with costs \>$14B/year. Furthermore, 30% of hospital admissions of older adults are drug related with 11% attributed to medication non-adherence and 17% to adverse drug reactions. While Alzheimer's disease (AD) \& type 2 diabetes mellitus (DM) individually have considerable morbidity \& mortality, they often occur together, worsening adverse outcomes, quality of life, \& care costs. This is especially true as the AD/DM combination creates a complex balancing act of med management \& symptom monitoring in older populations. While the goal is to keep older adults with dementia at home as long as possible, these challenges lead to untold personal \& family suffering, as well as billions in potentially avoidable healthcare costs annually. The HiDO-ALZ platform will solve these challenges by automating medication administration for PwD to eliminate mismanagement, decrease caregiver burden, reduce healthcare utilization, and facilitate PwD to age in place. HiDO is being developed as an automated, AI driven medication dispensing and direct observation platform to optimize adherence. The device integrates medication dispensing, dose administration time, medication synchronization, \& pair of front-facing cameras to validate the right meds, right route, right time, right dosage to the right patient (5R's). Cameras record every dose using facial recognition \& provide real -time medication consumption recordings. Through cloud connectivity, providers \& caregivers have access to video observation logs, dose administration time, adherence trends, \& longitudinal adherence via web dashboard. Patients \& caregivers can easily setup complex medication protocols in minutes using a smartphone app. The device then alerts patients and dispenses up to 7 different types of meds simultaneously, with up to 90 days of medication. Connected data sources including remote blood pressure and weight measurements, as well as electronic health record lab results and videoconferencing integrate in a single dashboard. The project will build on successful Phase I, in which the medication dispensing unit was updated with modifications for dementia, passed all bench testing, and was successfully validated in pilot usability with dementia subjects. Phase II will expand the foundation with four Aims: 1) Enhance device with remote sensors for diabetes management, expanded data integration, and video conferencing, 2) Test enhanced platform for usability in dementia subjects, 3) Transition the design to formal manufacturing process to ensure system meets performance standards and regulatory requirements \& produce pre-production devices for testing, \& 4) Conduct in-home clinical trial to demonstrate adherence and efficacy.

Para-Probiotic Oral Care in Periodontal Patients With Type 2 Diabetes

This randomized controlled clinical trial aims to evaluate the effectiveness of a para-probiotic-based oral care protocol in improving periodontal health and glycemic control in patients with type 2 diabetes mellitus (T2DM). A total of 40 adult patients (aged 18-70) with diagnosed periodontitis and T2DM will be enrolled and randomly assigned to two treatment groups. Both groups will receive standard non-surgical periodontal therapy. The test group will use para-probiotic toothpaste and mouthwash (Biorepair Plus Parodontogel and Biorepair Plus mouthwash) twice daily for 15 days after each recall visit, while the control group will use toothpaste and mouthwash containing 0.20% chlorhexidine on the same schedule. Clinical evaluations will be conducted at baseline (T0), 3 months (T1), and 6 months (T2), assessing key periodontal parameters including clinical attachment level (CAL), bleeding on probing (BoP), probing pocket depth (PPD), plaque index (PI), and glycemic control via hemoglobin A1c (HbA1c) levels. Patient satisfaction with treatment will be assessed using a questionnaire at T1 and T2. The primary objective is to evaluate the change in CAL from baseline to 6 months. Secondary objectives include the evaluation of changes in BoP, PPD, PI, HbA1c, and patient-reported satisfaction. This study seeks to determine whether para-probiotic oral care products can offer clinical benefits for periodontal disease management and systemic glycemic control in diabetic patients, potentially serving as a natural adjunct to conventional periodontal therapy.

Integrating New Skills Into Diabetes Education With CGM

This study is designed to test the preliminary efficacy of a three-stage continuous glucose monitor (CGM) integration program for older adults who are taking insulin. This study will learn if a three-stage CGM integration program ("intervention") that includes sessions focused on CGM technology skills, data skills, and lifestyle skills impacts CGM wear-time, glycemic metrics, and participant-reported outcomes, compared to two standard CGM training approaches ("comparators"). Following a screening visit and baseline data collection, participants will be randomized to either the intervention or one of the two comparator arms for 6 weeks. The intervention involves three educational sessions over 4 weeks. The first session will be in-person and subsequent sessions will be virtual. Participants in the intervention may receive 1-2 additional individualized training sessions to review CGM skills. The first comparator (Comparator 1) will receive a one-time clinic-based CGM training. The second comparator (Comparator 2) will be provided with a comprehensive informational pamphlet about CGM. All participants will complete outcomes data collection at 6 weeks. The study will also explore participant experiences through a series of semi-structured interviews with a subset of purposively selected participants and their care partners to identify opportunities for scaling the intervention to a broader population. An extension phase of the study will evaluate long-term CGM use and associated outcomes 3- and 6-months post-intervention. Lastly, we will run an additional small sub-study where consented care partners of participants will attend the intervention or comparator sessions alongside the study participant and provide care partner-specific data.

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (IRIS-CKD) (Program 2)

IRIS-CKD is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Implementation pRogram to Improve Screening and Management for CKD in Diabetes (Program 1) (IRIS-CKD)

IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.

Using Continuous Glucose Monitoring to Quantify the Effects of NOURISH's Culturally Modified Meals on Asian Americans With Type 2 Diabetes

The investigators are hoping to determine whether tailoring the diet of someone with type 2 diabetes to their ethnic group while following American Diabetes Association guidelines can make a significant difference in their blood sugar controls. Participants will be required to wear a Continuous Glucose Monitor (CGM) for 1-month so that the investigators can compare blood sugar levels when participants are eating their routine diet vs. the culturally tailored diabetes diet.

Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes

This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.

Cranberry Proanthocyanidins and Lactobacilli for Recurrent UTI Prevention in Type 2 Diabetes

The purpose of this prospective, single-arm feasibility study was to evaluate the operational feasibility, tolerability, safety, and exploratory clinical outcomes of an oral supplement combining standardized cranberry proanthocyanidins (PACs) and a multi-strain Lactobacillus formulation in women with type 2 diabetes mellitus and a documented history of recurrent urinary tract infections (rUTIs). Participants received a 60-day active intervention consisting of a combined capsule taken twice daily, followed by a 120-day observation period without study intervention, for a total follow-up duration of 180 days. Primary feasibility outcomes included screening and enrollment metrics, retention rate at day 180, and tolerability/adverse event rates. Exploratory endpoints included the incidence of microbiologically confirmed symptomatic UTIs and changes in antibiotic prescription rates compared with pre-enrollment history.