Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

Chronic Kidney Disease Clinical Trial

Official title:

Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407627
• Other study ID #: UCalgary Sugar Study
• Secondary ID: AIHSUniversity o
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: May 2021

Study information

• Verified date: May 2022
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• Fructose
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

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in filtration fraction	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	change in blood pressure in response to angiotensin II challenge	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