Clinical trial NCT01407627: Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
Official title: Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: human
fructose
dextrose
renin angiotensin system
kidney
renal hemodynamics
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2011-08-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

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:

1. The renal and mean arterial pressure (MAP) response to an AngII challenge.
2. Reactive changes in circulating levels of renin and aldosterone with graded AngII challenge.

PRIMARY HYPOTHESES: Ingestion of fructose in healthy subjects will result in:

1. A decrease in renal and systemic sensitivity to infused AngII.
2. A decrease in the reactive changes in renin and aldosterone with graded AngII challenge.

Eligibility criteria: 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

Primary outcomes:
measure: Change in filtration fraction
timeFrame: after 2 weeks of ingestion of fructose compared to baseline value
Secondary outcomes:
measure: change in blood pressure in response to angiotensin II challenge
timeFrame: change after 2 weeks of fructose ingestion
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Sofia B Ahmed, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References: