Cirrhosis-Diabetes

Glucose Metabolism Disorders Clinical Trial

— CH-DM  

Official title:

Prevalence and Clinical Characteristics of the Patients With Liver Cirrhosis and Different Glucose Metabolism Disorders - A Prospective Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01396954
• Other study ID #: CREED-ENDO
• Status: Active, not recruiting
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 18, 2011
• Start date: November 2007
• Est. completion date: August 2012

Study information

• Verified date: November 2007
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Glucose metabolism disorders (GMD) can be present in an overt and a subclinical way. They have negative impact in survival of patients with liver cirrhosis (LC). Their prevalence has not been determined in compensated cirrhotic patients.

Description:

Overt Diabetes Mellitus (DM) is observed in 21 to 40% of patients with liver cirrhosis (LC). There are two ways in which DM is related to LC: firstly, type 2 diabetes mellitus (T2DM), which has a genetic component and is often associated with metabolic syndrome (obesity, hypertriglyceridemia, and hypertension), causes chronic liver disease (steatosis, steatohepatitis, and LC Secondly, LC may cause impaired glucose tolerance (IGT) and DM. During the initial stages of LC these metabolic disorders are subclinical as can only be detected by an oral glucose tolerance test (OGTT). As liver disease progresses, DM becomes clinically evident.

Diabetes mellitus secondary to LC is known as "hepatogenous diabetes" (HD). Although it has been accepted that the LC is a diabetogenic condition, HD is not recognized by the American Diabetes Association and the WHO. Cirrhosis caused by alcohol, HCV, and hemochromatosis are more frequently associated to HD than other etiologies . It has been observed that HCV core protein induces insulin resistance (IR), steatosis, and DM regardless of body mass index (BMI). Patients with chronic alcoholism often have chronic pancreatic damage resulting in DM . In short, T2DM and HD have different etiology, but they seem to have similar pathophysiologic mechanisms for liver function deterioration. They increase the risk of complications and death.

In recent years, the incidence of obesity has increased alarmingly in the world, particularly in the Western countries . In Mexico, overweight and obesity, which are suffered by about 70% of the adult population are a serious public health problem,. This figure puts this country in second place in the world, behind only the United States of America. The incidence of T2DM and metabolic syndrome has increased rapidly in our country . They have became the most common causes of cryptogenic cirrhosis in Mexico. Many published studies, which have reviewed the prevalence of DM in cirrhotic patients, do not make a distinction between T2DM and HD; additionally, subclinical glucose metabolism disorders (GMD) are not routinely identified, so the magnitude of the problem has been underestimated. On the other hand, the clinical and biochemical features of cirrhotic patients with different GMD are not known at present. The clinical distinction of GMD may be useful for prognosis and therapeutic purposes. Based on the aforementioned, the objectives of the present study were: a) To establish the prevalence of clinical and subclinical forms of GMD (T2DM, HD, IGT) in a cohort of patients with compensated LC of diverse etiology; and b) To determine the clinical and biochemical characteristics of patient with these different GMD and to find whether there are significant differences among them..

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: August 2012
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• the presence of biopsy- or clinically diagnosed liver cirrhosis; clinically compensated cirrhosis; age above 18 years; and any sexExclusion Criteria:

• Patients with complications due to liver disease (such as hepatocellular carcinoma, alcoholic hepatitis, active gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and severe infection)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez