DiabetesFFAADANCT00721617
FFA Hypertension and Inflammation in Lean and Obese Subjects
A study testing Intralipid 20%, Normal Saline and Oral fat load in people with Diabetes and Hypertension, run by Emory University at 1 site in United States.
Trial summary
Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Obesity
- What is being tested?
- Intralipid 20%, Normal Saline and Oral fat load
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females
- Obese subjects (body mass index (BMI) ≥ 30 kg/m^2)
- 18 and 65 years
- Blood pressure reading < 140/80 mm Hg and no prior history of hypertension
Who cannot join
- History of diabetes mellitus
- History of hypertension
- Fasting triglyceride levels > 250 mg/dL
- Liver disease (ALT 2.5x > upper limit of normal)
- Serum creatinine ≥1.5 mg/dL
- Smokers, drug or alcohol abuse
- Mental condition rendering the subject unable to understand the scope and possible consequences of the study
- Female subjects who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects
Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.
Read the detailed description
Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.
- Conditions
- Diabetes, Hypertension, Obesity
- Being tested
- Intralipid 20%, Normal Saline, Oral fat load
- Medical subject headings
- Diabetes Mellitus, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid 20%Other
Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours.
Normal SalineOther
Lean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours.
Oral fat loadOther
Lean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours).
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects | Active comparator | Obese normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) Receives: Other: Intralipid 20%; Other: Normal Saline; Other: Oral fat load |
| Lean subjects | Active comparator | Lean normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) Receives: Other: Intralipid 20%; Other: Normal Saline; Other: Oral fat load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow-mediated Dilation From Baseline to 4 Hours
Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.
Measured: Baseline, 4 hours
Change in Systolic Blood Pressure From Baseline to 4 Hours
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.
Measured: Baseline, 4 hours
Change in Systolic Blood Pressure From Baseline to 8 Hours
Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.
Measured: Baseline, 8 hours
Change in Diastolic Blood Pressure From Baseline to 4 Hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.
Measured: Baseline, 4 hours
Change in Diastolic Blood Pressure From Baseline to 8 Hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.
Measured: Baseline, 8 hours
Secondary outcomes (16)
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours
Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 4 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change is the difference between 4 hour FFA levels from baseline FFA levels.
Measured: Baseline, 4 hours
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours
Blood samples were collected for measurement of free fatty acids (FFA) at baseline and 8 hours after each infusion. FFA levels were determined by colorimetric method. Current guidelines identify normal range of FFA level as less than 0.72 mmol/L. Elevated plasma levels of FFA indicate a greater rate of insulin resistance. Change iis the difference between 8 hour FFA levels from baseline FFA levels.
Measured: Baseline, 8 hours
Change in Triglyceride Levels From Baseline to 4 Hours
Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 4 hour triglyceride levels from baseline triglyceride levels.
Measured: Baseline, 4 hours
Change in Triglyceride Levels From Baseline to 8 Hours
Blood samples were collected for measurement of triglycerides at baseline and 4 hours after each infusion. Triglyceride levels were measured on CX7 Chemistry Analyzer. Current guidelines identify normal range of triglyceride level as less than 150 mg/dL. Elevated levels of triglycerides are associated with an increased risk of developing heart disease. Change is the difference between 8 hour triglyceride levels from baseline triglyceride levels.
Measured: Baseline, 8 hours
Plasma Glucose Levels for Saline Infusion
Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Measured: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Intralipid Infusion
Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Measured: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Dextrose Infusion
Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Measured: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Intralipid/Dextrose Infusion
Blood samples were collected for measurement of plasma glucose levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Plasma glucose was measured on CX7 Chemistry Analyzer. Current guidelines identify normal fasting glucose as less than 100 mg/dL. High levels of glucose most frequently indicates diabetes.
Measured: Baseline, 4 hours, 8 hours
Insulin Levels for Saline Infusion
Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Measured: Baseline, 4 hours, 8 hours
Insulin Levels for Intralipid Infusion
Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid infusion, and 8 hours after intralipid infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Measured: Baseline, 4 hours, 8 hours
Insulin Levels for Dextrose Infusion
Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Measured: Baseline, 4 hours, 8 hours
Insulin Levels for Intralipid/Dextrose Infusion
Blood samples were collected for the measurement of insulin levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. Insulin was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal insulin levels as 8.8 μU/mL for men and 8.4 for women. High levels of insulin most frequently indicate insulin resistance or hypoglycemia, if paired with a low glucose level. Low levels of insulin paired with high glucose level can indicate diabetes.
Measured: Baseline, 4 hours, 8 hours
C-peptides Levels for Saline Infusion
Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after saline infusion, and 8 hours after saline infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
Measured: Baseline, 4 hours, 8 hours
C-peptides Levels for Intralipid Infusion
Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after Intralipid infusion, and 8 hours after Intralipid infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
Measured: Baseline, 4 hours, 8 hours
C-peptides Levels for Dextrose Infusion
Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after dextrose infusion, and 8 hours after dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
Measured: Baseline, 4 hours, 8 hours
C-peptides Levels for Intralipid/Dextrose Infusion
Blood samples were collected for the measurement of C-peptide levels at baseline, 4 hours after intralipid/dextrose infusion, and 8 hours after intralipid/dextrose infusion. C-peptide was measured in plasma using a solid phase, two-site sequential chemiluminescent immunometric assays on the DPC Immulite analyzer. Current guidelines identify normal C-peptide levels as 0.51 to 2.72 ng/mL.
A high level of C-peptide generally indicates a high level of endogenous insulin production. This may be in response to a high blood glucose caused by glucose intake and/or insulin resistance. A high level of C-peptide is also seen with insulinomas and may be seen with low blood potassium, Cushing syndrome, and renal failure. A low level of C-peptide is associated with a low level of insulin production. This can occur when insufficient insulin is being produced by the beta cells, with diabetes for example, or when production is suppressed by treatment with exogenous insulin.
Measured: Baseline, 4 hours, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721617
- Sponsor's protocol ID
- IRB00009277
- Acronym
- FFAADA
- Status last verified
- Jul 2015
- First submitted
- 26 Jun 2008
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Fatty Acids-Induced Hypertension, Endothelial Dysfunction, Inflammation, Insulin Resistance, and Autonomic Dysfunction in Lean and Obese Subjects
- ClinicalTrials.gov ID
- NCT00721617
- Acronym / sponsor ID
- FFAADA / IRB00009277
- Conditions
- Diabetes, Hypertension, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Jul 2008 (estimated)
- Results
- Posted 27 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although a large number of obese patients develop high blood pressure, the cause is unknown. The purpose of this study is to look at the effect of high fatty acids (a type of fat) in the development of high blood pressure in obese people.
Detailed description
Recent studies indicate that increased levels of a circulating fat (free fatty acids or FFAs) increases blood pressure, impairs endothelial (vascular) function, and increases inflammatory markers in subjects with and without diabetes. The effects of FFA on blood pressure and vasculature have not been fully investigated. A group of 12 obese nondiabetic, normotensive subjects will be admitted to the Grady Clinical Research Center (GCRC) on separate 4 occasions. Research subjects will receive, in random order, a 8-hour intravenous (IV) infusion of Intralipid 20% at 40 mL/h (a fat solution), 8-hour IV infusion of normal saline at 40 mL/h, 8-hour IV infusion of dextrose (sugar) 10% at 40 mL/h, and a 8-hour intravenous (IV) infusion combination of Intralipid 20% and dextrose 10% at 40mL/h.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese subjects | Active comparator | Other: Intralipid 20%, Other: Normal Saline, Other: Oral fat loadObese normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) |
| Lean subjects | Active comparator | Other: Intralipid 20%, Other: Normal Saline, Other: Oral fat loadLean normotensive subjects will receive 24 hour challenges on 3 separate occasions, in a random order, with IV Normal Saline at 20ml/hour, IV Intralipid (20% solution at 20 ml/hour and an oral fat load (96g/24 hours) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or females
- Obese subjects (body mass index (BMI) ≥ 30 kg/m^2)
- 18 and 65 years
- Blood pressure reading < 140/80 mm Hg and no prior history of hypertension
Key exclusion criteria (8 listed)
- History of diabetes mellitus
- History of hypertension
- Fasting triglyceride levels > 250 mg/dL
- Liver disease (ALT 2.5x > upper limit of normal)
- Serum creatinine ≥1.5 mg/dL
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 |
|---|---|---|
| Intralipid 20%Lean and obese normotensive subjects will receive Intralipid 20% infusion. Intralipid is an oil-in-water emulsion derived from egg phospholipids, soybean, and glycerol. The Intralipid 20% long-chain triglyceride emulsion contains: 200 g of soy bean oil; 12 g of egg yolk; 25 g of glycerol. The emulsion is composed of the following free fatty acids (FFAs): linoleic acid: 50%, oleic acid: 26%, palmitic acid: 10%, stearic acid: 9%, egg yolk, phospholipids: 3.5% It will be given intravenously at 20 ml/hr (96 g/24 h) for 24 hours. | Other | Lean subjects, Obese subjects |
| Normal SalineLean and obese normotensive subjects will receive normal saline at 20 ml/hr for 24 hours. | Other | Lean subjects, Obese subjects |
| Oral fat loadLean and obese normotensive subjects will receive an oral fat load at 96 g/24hr. The oral liquid fat load will be given in equal amounts (16 g) every 4 hours (total 96 g over 24 hours). | Other | Lean subjects, Obese subjects |
Primary outcome
Change in Flow-mediated Dilation From Baseline to 4 Hours
Time frame: Baseline, 4 hours
Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. FMD is expressed as the change in diameter from baseline to 4 hours.
Change in Systolic Blood Pressure From Baseline to 4 Hours
Time frame: Baseline, 4 hours
Systolic blood pressure is the amount of pressure the heart generates when pumping blood through the arteries to the body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour systolic blood pressure from baseline systolic blood pressure.
Change in Systolic Blood Pressure From Baseline to 8 Hours
Time frame: Baseline, 8 hours
Systolic blood pressure is the amount of pressure your heart generates when pumping blood through your arteries to the rest of your body. Current guidelines identify normal systolic blood pressure as lower than 120 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour systolic blood pressure from baseline systolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 4 Hours
Time frame: Baseline, 4 hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 4 hour diastolic blood pressure from baseline diastolic blood pressure.
Change in Diastolic Blood Pressure From Baseline to 8 Hours
Time frame: Baseline, 8 hours
Diastolic blood pressure is the amount of pressure in your arteries when your heart is at rest between beats. Current guidelines identify normal diastolic blood pressure as lower than 80 mmHg. Blood pressure was measured in triplicate with a manual cuff prior to and every 4 hours during the 8 hour infusion with subjects in supine position. Change is the difference between 8 hour diastolic blood pressure from baseline diastolic blood pressure.
16 secondary outcomes
Change in FFA (Free Fatty Acid) Levels From Baseline to 4 Hours
Time frame: Baseline, 4 hours
Changes in FFA (Free Fatty Acid) Levels From Baseline to 8 Hours
Time frame: Baseline, 8 hours
Change in Triglyceride Levels From Baseline to 4 Hours
Time frame: Baseline, 4 hours
Change in Triglyceride Levels From Baseline to 8 Hours
Time frame: Baseline, 8 hours
Plasma Glucose Levels for Saline Infusion
Time frame: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Intralipid Infusion
Time frame: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
Plasma Glucose Levels for Intralipid/Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
Insulin Levels for Saline Infusion
Time frame: Baseline, 4 hours, 8 hours
Insulin Levels for Intralipid Infusion
Time frame: Baseline, 4 hours, 8 hours
Insulin Levels for Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
Insulin Levels for Intralipid/Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
C-peptides Levels for Saline Infusion
Time frame: Baseline, 4 hours, 8 hours
C-peptides Levels for Intralipid Infusion
Time frame: Baseline, 4 hours, 8 hours
C-peptides Levels for Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
C-peptides Levels for Intralipid/Dextrose Infusion
Time frame: Baseline, 4 hours, 8 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Guillermo Umpierrez, MD principal investigator
Emory 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 Intralipid 20%, Normal Saline and Oral fat load in people with Diabetes and Hypertension, run by Emory University 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 27 Jul 2015. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Flow-mediated Dilation From Baseline to 4 Hours (time frame: Baseline, 4 hours). The study lists 5 primary outcomes in all. 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 27 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.