Treatment Trials

126 Clinical Trials for Various Conditions

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COMPLETED
Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
Description

Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.

COMPLETED
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
Description

The purpose of the study was to evaluate the blood pressure (BP)-lowering efficacy of the combination of aliskiren and valsartan, as initial therapy, compared to valsartan monotherapy in Type II Diabetic patients with Stage II hypertension.

Conditions
RECRUITING
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Description

People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.

COMPLETED
Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes
Description

The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.

COMPLETED
Evaluation of Blood Pressure Reduction, Safety, and Tolerability of Canagliflozin in Patients With Hypertension and Type 2 Diabetes Mellitus on Stable Doses of Anti-hyperglycemic and Anti-hypertensive Agents
Description

The purpose of this study is to evaluate the effect of canagliflozin (JNJ-28431754) on blood pressure reduction, compared to placebo, in patients with hypertension and type 2 diabetes mellitus and who are on stable doses of anti-hyperglycemic and anti-hypertensive agents. Overall safety and tolerability of canagliflozin will be assessed.

COMPLETED
INV-144 Versus Losartan in Hypertension and Type 2 Diabetes Mellitus Patients With Macroalbuminuria
Description

A randomized, double-blind, active control trial to determine the safety, efficacy and pharmacokinetics of INV-144 versus losartan potassium plus placebo in subjects with hypertension and Type 2 diabetes mellitus with nephropathy as evidenced by albuminuria.

RECRUITING
Wild Blueberries for Gut, Brain, and Heart Health in Adults with High Blood Pressure
Description

The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.

COMPLETED
Free Fatty Acid-Induced Hypertension in Obese Subjects With Type 2 Diabetes
Description

Insulin resistance has been implicated as the central pathogenetic feature of cardiovascular risk factor cluster that includes hypertension, impaired glucose tolerance, diabetes, dyslipidemia, and hemostatic disorders. Recent evidence suggests that increased levels of free fatty acids (FFA) in obese subjects is a leading candidate in the pathogenesis of insulin resistance (1-4). In our preliminary studies on the effect of FFA on insulin secretion and action (lipotoxicity), we have observed that the infusion of Intralipid/heparin to increase FFA \~ four-fold-baseline levels for 48 hours results in a significant and reproducible raise in systolic and diastolic blood pressure (BP) in obese African American subjects with and without diabetes. The increase in blood pressure is apparent after 12 hours of infusion, reaching a peak increment of 32 mm Hg in systolic and 14 mm Hg in diastolic pressure at 24 hours. These preliminary findings indicate that, in addition to the well-known effect on insulin resistance, sustained elevation of FFA results in the development of an acute metabolic syndrome.

COMPLETED
24 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Black/African American Patients With Type 2 Diabetes Mellitus and Hypertension
Description

This trial is designed to investigate the efficacy and safety of empagliflozin compared with placebo in hypertensive black/African Americans with type 2 Diabetes Mellitus. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and BP lowering effects of empagliflozin in hypertensive African American patients with type 2 Diabetes Mellitus could provide clinically highly relevant, new information for the use of empagliflozin. Essential hypertension is four times more common in African Americans than in Caucasians. One of the risk factors for hypertension is sodium sensitivity and approximately one third of the essential hypertensive population is responsive to sodium intake. There is a higher association of hypertension with sodium sensitivity in African American patients with type 2 Diabetes Mellitus. The treatment duration of this trial (24 weeks) will enable assessment of the clinically relevant endpoint of a decrease in HbA1c, a well accepted measurement of chronic glycaemic control and the key secondary endpoints of decreases in systolic BP (SBP) and diastolic BP (DBP) at 12 and 24 weeks.

COMPLETED
Exercise Training in Type 2 Diabetes and Hypertension
Description

The coexistence of diabetes and hypertension is damaging to cardiac and peripheral vascular structure and function. Although several health organizations endorse exercise training as a treatment for type 2 diabetes, most studies of exercise and diabetes have focused on controlling blood sugar but not on cardiovascular health. The aim of this study is to determine if exercise training reduces blood pressure and improves cardiovascular health in persons who have both type 2 diabetes and hypertension. An equal number of men and women will be enrolled, and another aim of the study is to examine gender differences in response to exercise training.

COMPLETED
Diabetes and Hypertension Self Management Program
Description

The purpose of this R15 project is to test the feasibility and effectiveness of a 12-week diabetes and hypertension self-management program using trained health coaches.

COMPLETED
Enhancing Diabetes and Hypertension Self-Management Rural Appalachian Patients In Patient-Centered Medical Homes
Description

The goal of this R34 planning project is to test the feasibility and acceptability of a 12-week modified diabetes and hypertension self-management program using trained Health Coaches.

COMPLETED
Dietary Approaches to Stop Hypertension for Diabetes
Description

The objective of the DASH4D trial is to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet that is typical of what many Americans with diabetes eat and (b) lower sodium intake vs. higher sodium intake on blood pressure (BP). The core design is a single-site, 4-period, crossover feeding study with 5-week periods. Participants are fed each of four isocaloric diets, presented in random order. The primary contrast of interest is DASH4D diet with lower sodium vs. comparison diet with higher sodium.

TERMINATED
Community Models for Hypertension and Diabetes Care for Refugees
Description

The project will investigate and improve a community health worker (CHW) based model for non-communicable disease (NCD) care in a humanitarian emergency.

WITHDRAWN
Ertugliflozin Versus Hydrochlorothiazide in Reducing Sympathetic Neural Overactivity in Patients With Hypertension and Recently-diagnosed Type 2 Diabetes.
Description

The sodium-glucose cotransporter 2 (SGLT2) inhibitors are an exciting new class of antidiabetic drugs that cause a modest reduction in high blood pressure and large reductions in the risk of cardiovascular disease (CVD) outcomes and renal outcomes in patients with advanced type 2 diabetes and very high CVD risk. However, the mechanistic underpinning of these CVD benefits is not well understood. Mechanistic studies are needed to define specific biologic targets and thus optimize therapeutic benefits. Type 2 diabetes mellitus is firmly established as a state of sympathetic neural overactivity, which may contribute to coexistent hypertension, heart failure, sudden cardiac death, macro- and micro-vascular complications of diabetes, and diabetic nephropathy. In patients recently diagnosed with Type 2 diabetes, microelectrode recordings of sympathetic nerve activity (SNA) targeted to the skeletal muscle circulation have shown both: 1. abnormally high resting (ambient) levels of sympathetic nerve activity; and 2. greatly exaggerated increases in sympathetic nerve activity during isometric (static) handgrip exercise. The purpose of the proposed study is to determine if Ertugliflozin, a SGLT2 inhibitor, constitutes an effective countermeasure against sympathetic overactivity in patients with diagnosed hypertension and recently diagnosed type 2 diabetes by normalizing the high resting level of muscle sympathetic nerve activity (SNA) as measured by intraneural microelectrodes in the peroneal nerve. Thus, an effective countermeasure is an urgent unmet medical need. The SGLT2 inhibitors hold exciting promise to address this need.

RECRUITING
Vitamin D and Immune Mechanisms of Hypertension in Type 2 Diabetics
Description

This trial will evaluate whether a particular type of circulating white blood cell, monocytes, from type 2 diabetics with high blood pressure and vitamin D deficiency vs. sufficiency will induce hormones that increase blood pressure.

TERMINATED
A Dose Finding Study to Assess the Effect of LIK066 Compared to Placebo or Empagliflozin in Patients With Type 2 Diabetes Mellitus and Heart Failure
Description

This was a dose-finding study to evaluate the efficacy, safety and tolerability of 3 different doses of LIK066 compared to placebo or empagliflozin in T2DM patients with heart failure

COMPLETED
Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC) in Patients With Stable Type 2 Diabetes and Hypertension
Description

To compare the safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects of 2 treatment regimens of IW-1973 tablet (40 mg per day) administered orally for 2 weeks to patients with stable type 2 diabetes mellitus and hypertension.

COMPLETED
A Phase 2 Trial of IW-1973, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Stable Type 2 Diabetes and Hypertension
Description

To evaluate the impact of escalating doses of IW-1973 on endothelial function \[using EndoPAT to measure fingertip small vessel pulse volume\], blood pressure (BP), and heart rate.

COMPLETED
Multi-clinic Action Trial to Control Hyperglycemia and Hypertension
Description

The MATCH2 Study (The Multi-clinic Action Trial to Control Hyperglycemia and Hypertension) is a randomized controlled trial comparing two educational approaches to improve glucose and blood pressure control in African American and Latino adults with type 2 diabetes. The study is being designed and implemented using a Community Based Participatory Research approach to optimize the two educational approaches. One approach, Enhanced Home Based Education, adapts a Community Health Worker (CHW) intervention from the protocol of the prior Mexican-American Trial of Community Health workers (MATCH). The other approach, Enhanced Clinic Based Education, uses a Certified Diabetes Educator (CDE) to deliver dietary and general self-management education. The study seeks to determine if Community Health Workers working as part of the primary care clinical team can reduce health disparities and improve outcomes among patients with type 2 diabetes.

COMPLETED
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Description

The purpose of this study is to study the effect of blocking the renin angiotensin system on urinary free light chain excretion as compared to urine microalbumin creatinine ratio in subjects with type 2 diabetes. The long term goal is to assess urinary free-light chains as a biomarker of earlier detection of kidney function impairment in subjects with diabetes mellitus.

TERMINATED
Evaluating the Effects of EECP on Circulation, Blood Glucose Level and Blood Pressure in Type 2 Diabetes Mellitus
Description

The purpose of this proposed Department of Defense study is to evaluate the effect of Enhanced External Counterpulsation (EECP) on circulation, blood glucose control and blood pressure of type 2 diabetic patients receiving EECP therapy.

COMPLETED
12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Description

This trial will evaluate safety and efficacy of BI 10773 in hypertensive patients with type 2 diabetes. Since hyperglycaemia and hypertension are key risk factors for both micro- and macrovascular complications, assessment of both glucose and blood pressure lowering effects of BI 10773 in hypertensive patients with type 2 diabetes could provide clinically highly relevant, new information for the use of BI 10773

COMPLETED
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes With Inadequately Controlled Hypertension on an ACEI or ARB and an Additional Antihypertensive Medication
Description

The purpose of this study is to learn if BMS-512148 (Dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB).The safety of this treatment will also be studied

Conditions
COMPLETED
A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
Description

The purpose of this study is to learn whether dapagliflozin, after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker. The safety of this treatment will also be studied.

Conditions
ACTIVE_NOT_RECRUITING
The TRIABETES - ARMMS-T2D Study: A Randomized Trial to Compare Surgical and Medical Treatments for Type 2 Diabetes
Description

This research study is being performed to begin to determine the effectiveness of two dominant bariatric surgery procedures versus an intensive lifestyle intervention to induce weight loss in patients and promote improvements in Type 2 diabetes mellitus (T2DM) in moderately obese patients. T2DM is currently the 6th leading cause of mortality in the United States and is a major cause of kidney failure, blindness, amputations, heart attack, and other vascular and gastro-intestinal dysfunctions. Traditionally, treatments include intensive lifestyle modifications with or without glucose lowering agents. Neither treatment alone, or in combination, results in complete resolution of diabetes and its potential long-term complications. Bariatric surgery has been proven as an effective treatment to accomplish sustained and significant weight loss for those with severe obesity and has been shown to induce long-term remission of T2DM. However, despite enthusiasm for these potential treatment options, it is not clear whether diabetes is influenced by the type of surgery or by the amount of weight lost or if bariatric surgery is more effective than non-surgical weight loss induced by diet and physical activity in T2DM patients with moderate BMIs (30-40kg/m2; Class I and Class II obesity, or approximately 65-95 pounds overweight depending on your height). More well-controlled studies are needed to more completely inform health care decision making and clinical practice in this area. This research study aims to obtain preliminary information regarding the effectiveness of two major types of bariatric surgery, Laparoscopic Roux-en-Y Gastric Bypass and Laparoscopic Adjustable Gastric Banding versus an intensive lifestyle intervention to induce weight loss with diet and increased physical activity.

COMPLETED
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Description

This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

COMPLETED
Telmisartan Fixed Dose Combination vs Amlodipine in Hypertensive Patients With Type 2 Diabetes Mellitus
Description

To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.

Conditions
COMPLETED
A Clinical Study to Evaluate Renal Hemodynamic Responses to Aliskiren in Patients With Type 2 Diabetes Mellitus
Description

The study objective was to assess the effect of single and multiple doses of aliskiren on renal plasma flow, glomerular filtration rate and to compare the effects of single and multiple doses of aliskiren versus captopril or irbesartan on renal blood flow, glomerular filtration rate, and retinal blood flow in patients with type 2 diabetes mellitus.

TERMINATED
Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus
Description

The purpose of this study is to evaluate the efficacy and safety of pioglitazone-azilsartan, once daily (QD), in subjects with type 2 diabetes mellitus with poor glycemic control.

Conditions