- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407627
Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
Fructose is an ingredient that is added to many of our foods. It is a cheaper, sweeter additive that can be found in everything from soda pop to yogurt to granola bars. In the last few years a significant number of studies have been published linking consumption of fructose with obesity, hypertension and more recently, kidney and cardiovascular disease.
Animal studies show a strong link between excessive ingestion of fructose and the development of kidney and cardiovascular disease mediated by the renin angiotensin system, a hormonal system whose activation is detrimental to both the kidney and the heart. There has been very little research done on the potentially pathophysiological relationship between a high fructose diet and kidney and cardiovascular disease in humans.
The investigators hypothesize that ingestion of fructose will result in upregulation of the renin angiotensin system in humans.
Cardiovascular disease in women is a significant risk factor. By having women participate who are on the birth control pill and as well as women who use non oral forms of birth control or no birth control, kidney function and cardiovascular health can be examined as it relates to in the influence oral hormones might play. How the kidney responds to the influence of sugar and fructose while a woman is on an oral birth control pill, may reveal mechanisms that could help us understand cardiovascular disease in women.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY AIM: To examine whether the physiologic and molecular responses to Angiotensin II (AngII) challenge differ in response to fructose intake as assessed by two independent means:
- The renal and mean arterial pressure (MAP) response to an AngII challenge.
- Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.
PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:
- A decrease in renal and systemic sensitivity to infused AngII.
- A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- University of Calgary
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age≥18 years,
- able to comprehend study and comply with high-salt diet
- kidney disease (on the approval of their nephrologist)
- on an oral birth control pill and non oral birth control and those not on birth control
Exclusion Criteria:
- cardiovascular disease (symptoms consistent with myocardial ischemia, previously documented myocardial ischemia, cardiac arrhythmias or valve abnormalities, or abnormal ECG at screening)
- cerebrovascular disease (transient ischemic attacks or stroke)
- hypertension (BP>140/90 or use of antihypertensive medications)
- diabetes mellitus (defined by history, use of hypoglycemic agents or a fasting glucose >7mmol/L)
- hyperlipidemia (LDL >4.5mmol/L or use of lipid-lowering agents)
- pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fructose First
|
Subjects will be randomized to one of 2 sequences: Sequence 1: Fructose (intervention) 200g daily x 14d followed by Dextrose (control) 200g daily x 14d Sequence 2: Dextrose (control) 200g daily x 14d followed by Fructose (intervention) 200g daily x 14d |
Active Comparator: Dextrose First
|
Subjects will be randomized to one of 2 sequences: Sequence 1: Fructose (intervention) 200g daily x 14d followed by Dextrose (control) 200g daily x 14d Sequence 2: Dextrose (control) 200g daily x 14d followed by Fructose (intervention) 200g daily x 14d |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in filtration fraction
Time Frame: after 2 weeks of ingestion of fructose compared to baseline value
|
To examine whether the physiologic and molecular responses to an Angiotensin II challenge differ in response to fructose intake as assessed by reactive changes in circulating levels of renin and aldosterone with a graded Angiotensin II challenge.
|
after 2 weeks of ingestion of fructose compared to baseline value
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in blood pressure in response to angiotensin II challenge
Time Frame: change after 2 weeks of fructose ingestion
|
To examine whether the physiologic and molecular responses to an Angiotensin II challenge differ in response to fructose intake as assessed by renal and mean arterial pressure (MAP) response to an Angiotensin II challenge.
|
change after 2 weeks of fructose ingestion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sofia B Ahmed, MD MMSc, University of Calgary
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCalgary Sugar Study
- AIHS (Other Grant/Funding Number: Establishment Grant)
- University of Calgary (Other Grant/Funding Number: RSO1020497)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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