Metabolic Syndrome in the ElderlyNCT00873964
Metabolic Syndrome in an Elderly Population is More Linked to Insulin Resistance Than to Obesity
An observational study of Metabolic Syndrome in the Elderly, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is the leading cause of death among men and women 65 years or older (1). Studies have shown that the risk for cardiovascular disease is higher in individuals with the Metabolic Syndrome (2). Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome in the Elderly
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jul 2013
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 156 obese (BMI 30-34 kg/m2), non-diabetic men and women between the ages of 60-80 years of age will be eligible to enroll in the study if they meet the following inclusion criteria: (1) BMI 30-34 kg/m2. (2) Ability and willingness to provide signed, witnessed informed consent.
Who may be able to join
- Approximately 156 obese (BMI 30-34 kg/m2) non-diabetic men and women between the ages of 60-80 years of age will be eligible to enroll in the study if they meet the following inclusion criteria:
- BMI 30-34 kg/m2
- Ability and willingness to provide signed, witnessed informed consent.
Who cannot join
- Diabetes mellitus. WHO diagnostic criteria for diabetes mellitus is fasting plasma glucose > 7.0 mmol/l (126 mg/dl) or 2-h plasma glucose > 11.1 mmol/l (200mg/dl).
- Subjects in this group experience increased premature mortality and increased risk of microvascular and cardiovascular complications (25).
- Subjects with clinically apparent cardiovascular disease including prior history of cardiac angina, MI, interventional percutaneous procedures, coronary artery bypass graft, congestive heart disease, cerebral vascular accident, peripheral vascular disease, and pulmonary embolus.
- Subjects with serum creatinine greater than 3.
- Subjects with moderate or severe COPD or on home oxygen.
- Subjects with serum total bilirubin greater than 4.
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- Subjects with concurrent infectious disease.
- Subjects with malignancy (except for prostate ca, or basal cell carcinoma of the skin) diagnosed within the last year, or on concurrent chemotherapy.
- Subjects receiving androgen or anti-androgen therapy.
- Hormone replacement therapy.
Trial locations and contacts
1 site in 1 country.
About this study
In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is the leading cause of death among men and women 65 years or older (1). Studies have shown that the risk for cardiovascular disease is higher in individuals with the Metabolic Syndrome (2). Metabolic Syndrome (MBS) is defined by the Adult Treatment Panel III (ATP III) guidelines as a group of risk factors that includes 3 or more of the following: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose (3). These factors place individuals at increased risk for the development of both cardiovascular disease (CVD) and diabetes mellitus (3). It is commonly held that insulin resistance is the driving force for the development of the MBS.
Although there is a significant increase in incidence of MBS in the elderly, there are few studies that specifically examined MBS in that population. The prevailing opinion is that the strikingly high prevalence of the MBS in the elderly is due to concurrent obesity - i.e., the population gains weight as it ages, and development of the MBS accompanies the weight gain.
Read more
However, while it is true that becoming obese may decrease insulin sensitivity, it has also been demonstrated that not all obese individuals are insulin resistant. Some studies suggest that up to 40% of obese individuals demonstrate normal insulin sensitivity (4). In addition, it is notable that the rate of increasing MBS in the population exceeds that of the rate of increasing BMI, suggesting that, while BMI may be a modulating factor, another factor independent of obesity also contributes to the development of MBS in the elderly.
It is the investigators hypothesize that the MBS in the obese elderly population is primarily linked to insulin resistance and not to obesity per se. The investigators propose to test this hypothesis by assessing MBS and insulin resistance in a population of obese elderly men and women and then determining whether or not the MBS tracks with insulin resistance.
- Conditions
- Metabolic Syndrome in the Elderly
- Keywords
- Metabolic Syndrome, Obesity, Elderly, Insulin Resistance
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome in the ElderlyStudies 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
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Terre Williams, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00873964
- Sponsor's protocol ID
- HM11534
- Status last verified
- Apr 2012
- First submitted
- 1 Apr 2009
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome in an Elderly Population is More Linked to Insulin Resistance Than to Obesity
- ClinicalTrials.gov ID
- NCT00873964
- Acronym / sponsor ID
- HM11534
- Conditions
- Metabolic Syndrome in the Elderly
- Keywords
- Metabolic Syndrome, Obesity, Elderly, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Mar 2009
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Apr 2009 (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.
In the United States cardiovascular disease (CVD) accounts for 1 in every 2.8 deaths and is the leading cause of death among men and women 65 years or older (1). Studies have shown that the risk for cardiovascular disease is higher in individuals with the Metabolic Syndrome (2). Metabolic Syndrome (MBS) is defined by the Adult Treatment Panel III (ATP III) guidelines as a group of risk factors that includes 3 or more of the following: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose (3). These factors place individuals at increased risk for the development of both cardiovascular disease (CVD) and diabetes mellitus (3). It is commonly held that insulin resistance is the driving force for the development of the MBS.
Although there is a significant increase in incidence of MBS in the elderly, there are few studies that specifically examined MBS in that population. The prevailing opinion is that the strikingly high prevalence of the MBS in the elderly is due to concurrent obesity - i.e., the population gains weight as it ages, and development of the MBS accompanies the weight gain.
However, while it is true that becoming obese may decrease insulin sensitivity, it has also been demonstrated that not all obese individuals are insulin resistant. Some studies suggest that up to 40% of obese individuals demonstrate normal insulin sensitivity (4). In addition, it is notable that the rate of increasing MBS in the population exceeds that of the rate of increasing BMI, suggesting that, while BMI may be a modulating factor, another factor independent of obesity also contributes to the development of MBS in the elderly.
It is the investigators hypothesize that the MBS in the obese elderly population is primarily linked to insulin resistance and not to obesity per se. The investigators propose to test this hypothesis by assessing MBS and insulin resistance in a population of obese elderly men and women and then determining whether or not the MBS tracks with insulin resistance.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 156 obese (BMI 30-34 kg/m2), non-diabetic men and women between the ages of 60-80 years of age will be eligible to enroll in the study if they meet the following inclusion criteria: (1) BMI 30-34 kg/m2. (2) Ability and willingness to provide signed, witnessed informed consent.
Key inclusion criteria (3 listed)
- Approximately 156 obese (BMI 30-34 kg/m2) non-diabetic men and women between the ages of 60-80 years of age will be eligible to enroll in the study if they meet the following inclusion criteria:
Key exclusion criteria (10 listed)
- Diabetes mellitus. WHO diagnostic criteria for diabetes mellitus is fasting plasma glucose > 7.0 mmol/l (126 mg/dl) or 2-h plasma glucose > 11.1 mmol/l (200mg/dl).
- Subjects in this group experience increased premature mortality and increased risk of microvascular and cardiovascular complications (25).
- Subjects with clinically apparent cardiovascular disease including prior history of cardiac angina, MI, interventional percutaneous procedures, coronary artery bypass graft, congestive heart disease, cerebral vascular accident, peripheral vascular disease, and pulmonary embolus.
- Subjects with serum creatinine greater than 3.
- Subjects with moderate or severe COPD or on home oxygen.
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 30 Apr 2012.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome in the Elderly, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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 3 inclusion and 10 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 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 30 Apr 2012.