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Glucose Metabolism DisordersCH-DMNCT01396954

Cirrhosis-Diabetes

An observational study of Glucose Metabolism Disorders, run by Hospital Universitario Dr. Jose E. Gonzalez.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glucose Metabolism Disorders
How many people
130 participants
Where
No sites listed yet
Study dates
Nov 2007to Aug 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)

Who cannot join

None listed.

About this study

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

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.

Read the 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..

Keywords
Liver cirrhosis, Diabetes mellitus, Hepatogenous diabetes, Oral glucose tolerance test, Insulin resistance.
Medical subject headings
Glucose Metabolism Disorders, Liver Cirrhosis, Diabetes Mellitus, Insulin Resistance

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2011 (estimated)
  2. Study startNov 2007
  3. Primary completionAug 2011 (estimated)
  4. Study completionAug 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01396954
Sponsor's protocol ID
CREED-ENDO
Acronym
CH-DM
Status last verified
Nov 2007
First submitted
18 Jul 2011
Last updated
19 Jul 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Glucose Metabolism Disorders, run by Hospital Universitario Dr. Jose E. Gonzalez.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2011.

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