Cirrhosis-Diabetes (CH-DM)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Hospital Universitario Dr. Jose E. Gonzalez.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01396954
First received: July 18, 2011
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition
Glucose Metabolism Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Clinical Characteristics of the Patients With Liver Cirrhosis and Different Glucose Metabolism Disorders - A Prospective Study.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Enrollment: 130
Study Start Date: November 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Detailed 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..

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We prospectively included patients with compensated liver cirrhosis who were admitted in the Regional Center for the Study of Digestive Diseases and the Liver Unit of the University Hospital and Faculty of Medicine

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Diego Garcia-Compean, Gastroenterology Service and Department of Internal Medicine, University Hospital
ClinicalTrials.gov Identifier: NCT01396954     History of Changes
Other Study ID Numbers: CREED-ENDO
Study First Received: July 18, 2011
Last Updated: July 18, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Liver cirrhosis
Diabetes mellitus
Hepatogenous diabetes
Oral glucose tolerance test
Insulin resistance.

Additional relevant MeSH terms:
Disease
Glucose Metabolism Disorders
Liver Cirrhosis
Metabolic Diseases
Digestive System Diseases
Liver Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014