ObesityNCT00911209
Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction
A study testing Dietitian counselling in people with Obesity and Heart Disease, run by Ragavendra Baliga at 1 site in United States.
Trial summary
The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obesity, Heart Disease, Weight Loss
- What is being tested?
- Dietitian counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2010
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age ≥ 21 years
- BMI ≥30
- Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg
- Echocardiographic EF >50%
- Echocardiographic evidence of diastolic dysfunction;
Who cannot join
- Patients receiving antihypertensive medications
- Patients receiving diabetic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives
The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.
Read the detailed description
You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours.
- Conditions
- Obesity, Heart Disease, Weight Loss, Diastolic Dysfunction
- Being tested
- Dietitian counselling
- Keywords
- Heart Disease, Obesity
- Medical subject headings
- Obesity, Heart Diseases, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietitian counsellingBehavioural
Once a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Intervention group at each session will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss (for example a person weighing 200 pounds will be encourage to lose at least 14 pounds). Receives: Behavioral: Dietitian counselling |
| No Intervention | No intervention | The standard of care group will receive information on Heart healthy diet at baseline visit and will return to a final visit about 28 weeks later. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if weight loss is associated with changes in separate components of cardiac function.
Measured: 32 weeks
Secondary outcomes (1)
Determine whether specific cardiac markers will be altered in patients with diastolic dysfunction treated with low caloric diet and exercise and if these levels will be altered in association with improvement in diastolic function.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startJul 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Terminated because funding was not found
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ragavendra Baliga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ragavendra Baliga, Ohio State University
- Investigators
- Ragavendra Baliga, MD, MBA,, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911209
- Sponsor's protocol ID
- 2007H0328
- Status last verified
- Oct 2012
- First submitted
- 28 May 2009
- Last updated
- 15 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Weight Loss on Diastolic Dysfunction in Overweight Pre-Hypertensives
- ClinicalTrials.gov ID
- NCT00911209
- Acronym / sponsor ID
- 2007H0328
- Conditions
- Obesity, Heart Disease, Weight Loss, Diastolic Dysfunction
- Keywords
- Heart Disease, Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated because funding was not found
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ragavendra BaligaUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Jun 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.
The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.
Detailed description
You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dietitian counsellingThe Intervention group at each session will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss (for example a person weighing 200 pounds will be encourage to lose at least 14 pounds). |
| No Intervention | No intervention | –The standard of care group will receive information on Heart healthy diet at baseline visit and will return to a final visit about 28 weeks later. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults age ≥ 21 years
- BMI ≥30
- Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg
- Echocardiographic EF >50%
- Echocardiographic evidence of diastolic dysfunction;
Key exclusion criteria (2 listed)
- Patients receiving antihypertensive medications
- Patients receiving diabetic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietitian counsellingOnce a week for 14 weeks then 1 monthly visit. Visits last 40-50 minutes | Behavioural | Intervention |
Primary outcome
Determine if weight loss is associated with changes in separate components of cardiac function.
Time frame: 32 weeks
1 secondary outcome
Determine whether specific cardiac markers will be altered in patients with diastolic dysfunction treated with low caloric diet and exercise and if these levels will be altered in association with improvement in diastolic function.
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Terminated because funding was not found). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
Ragavendra Baliga, MD, MBA, principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietitian counselling in people with Obesity and Heart Disease, run by Ragavendra Baliga 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 15 Oct 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?
The study was stopped early (reason given: Terminated because funding was not found). 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.
What does the primary outcome measure?
Determine if weight loss is associated with changes in separate components of cardiac function. (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
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 15 Oct 2012.