Treatment Trials

20 Clinical Trials for Various Conditions

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RECRUITING
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes
Description

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

RECRUITING
REACH-Es: Adapting a Digital Health Tool to Improve Diabetes Medication Adherence Among Latino Adults
Description

Latino individuals, the fastest growing ethnic minority population in the United States, have a higher prevalence of type 2 diabetes and diabetes-related complications, and are more likely to report inconsistent use of diabetes medications than non-Hispanic White individuals. The proposed project will test an interactive text message-based tool tailored to address barriers to taking diabetes medications that are relevant to Latino adults. If found feasible, acceptable, and usable, this intervention could serve as a scalable tool to improve diabetes management and reduce diabetes-related complications among Latino adults in the United States.

COMPLETED
Effect of Cinnamon on Glucose and Lipid Levels in Non-Insulin Dependent Type 2 Diabetes Mellitus
Description

The purpose of this study is to determine the effects of cinnamon on serum glucose and lipid levels in people with non-insulin dependent type 2 diabetes mellitus.

COMPLETED
Effect of Liraglutide (Victoza) on Inflammation in Human Adipose Tissue and Blood
Description

The objective of this study is to test the hypothesis that liraglutide (commonly known as Victoza) can promote an anti-inflammatory macrophage phenotype in human adipose tissue and blood, thereby reducing localized and systemic inflammation which are risk factors for cardiovascular disease and may contribute to hyperglycemia. This will be done after 4 weeks of treatment during which weight will remain stable, and again after 12 weeks, during which liraglutide-related weight loss occurs.

COMPLETED
Tablet-Aided BehavioraL Intervention EffecT on Self-management Skills
Description

The purpose of this project is two-fold: (1) to determine the feasibility of recruiting rural African American (AA) adults in South Carolina (SC) for assessing the usefulness of tablet-based resources in good diabetes self-management behaviors, and (2) to test a tablet-aided intervention for improving diabetes self-management behaviors

ACTIVE_NOT_RECRUITING
Technology Intensified Diabetes Education Study in African Americans
Description

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.

COMPLETED
Telephone Delivered Behavioral Skills Intervention for Blacks With T2DM
Description

Blacks or African Americans have greater risk of and are more likely to die from type 2 diabetes (T2DM). Major barriers to effective diabetes care for Blacks include poor diabetes knowledge, self-management skills, empowerment, and perceived control. Few prior studies have tested interventions to address these barriers in combination, especially among Blacks who have the greatest burden of diabetes related complications. This study provides a unique opportunity to address this gap in the literature by testing the efficacy of separate and combined telephone-delivered, diabetes knowledge and motivation/behavioral skills training intervention in high risk Blacks with poorly controlled T2DM. The findings of this study, if successful, will provide new information on how to improve quality of care for diabetes in ethnic minorities and reduce the disproportionate burden of diabetes complications and deaths in this population.

COMPLETED
Financial Incentives Telephone Education and Skills Trial in African Americans With Diabetes (FITEST)
Description

The aim of this study is to test the efficacy of financial incentives augmented telephone-delivered diabetes education and skills training intervention in improving HbA1c levels in African Americans (AA) with type 2 diabetes (T2DM).

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.

UNKNOWN
Automated SMS-Based Appointment Validation Tool
Description

Medic Mobile conceptualized and proposed the creation of an SMS-based appointment validation tool to automate appointment confirmation and rescheduling. Working in parallel with the San Mateo Medical Center (SMMC) electronic medical records (EMR) system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. While simple in concept, this tool aims to free up scarce clinical resources which are currently allocated to daily patient phone call reminders. With funding from a Bay Area foundation, the investigators will develop and pilot this open-source software tool in a 12-month randomized-controlled trial, slated to begin in October 2012. The endpoints of the study will aim to demonstrate improvements in both appointment adherence and glycemic control.

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
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics
Description

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.

TERMINATED
The Effect of a Probiotic on Hepatic Steatosis
Description

Non-alcoholic fatty liver disease (NAFLD) is an accumulation of fat and fibrous tissue in the liver. It is the most common cause of chronic liver disease in the United States. The exact cause of NAFLD is unknown, but it is more common among people with conditions such as adult-onset diabetes. NAFLD can strike people of all ages but most often affects adults between the ages of 40 and 60. Research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. Probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. Because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for NAFLD.

Conditions
ACTIVE_NOT_RECRUITING
CharacterIzation of Adult Onset Autoimmune Diabetes
Description

The purpose of the study is to identify new biomarkers of Adult Onset Autoimmune Diabetes (AOnAD).

Conditions
RECRUITING
Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes
Description

The brief purpose of this research study is to learn about the safety and efficacy of intra-arterial administration of CELZ-201 in patients with newly diagnosed Type 1 Diabetes Mellitus (T1D).

COMPLETED
Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study
Description

The goal of the study is to characterize preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.

COMPLETED
Study to Evaluate the Efficacy of Androxal in Controlling Blood Glucose in Men With Type-2 Diabetes Mellitus
Description

The purpose of this study is to determine the effect the investigative drug has on glycemic control in men with type 2 diabetes mellitus (T2DM) and secondary hypogonadism

TERMINATED
Protege Encore Study- Clinical Trial of Teplizumab (MGA031) in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Description

The primary purpose of this study is to determine whether teplizumab (MGA031) infusions lead to greater reductions in insulin requirements in conjunction with near normal blood sugar control compared to placebo in patients recently diagnosed with type 1 diabetes.

COMPLETED
The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Description

The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.

COMPLETED
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Description

The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other physician determined standard of care treatments. DEFEND-1 is now closed to enrollment. DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require subjects with new onset type 1 diabetes. Please check back here for more details. In the meantime, established and new onset type 1 diabetes patients in North America are welcome to consider the TTEDD study: http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD\&rank=1