Glucose Metabolism DisordersCH-DMNCT01396954
Cirrhosis-Diabetes
An observational study of Glucose Metabolism Disorders, run by Hospital Universitario Dr. Jose E. Gonzalez.
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..
- Conditions
- Glucose Metabolism Disorders
- 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.
- First posted19 Jul 2011 (estimated)
- Study startNov 2007
- Primary completionAug 2011 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Clinical Characteristics of the Patients With Liver Cirrhosis and Different Glucose Metabolism Disorders - A Prospective Study.
- ClinicalTrials.gov ID
- NCT01396954
- Acronym / sponsor ID
- CH-DM / CREED-ENDO
- Conditions
- Glucose Metabolism Disorders
- Keywords
- Liver cirrhosis, Diabetes mellitus, Hepatogenous diabetes, Oral glucose tolerance test, Insulin resistance.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.