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Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans

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ClinicalTrials.gov Identifier: NCT01407627
Recruitment Status : Recruiting
First Posted : August 2, 2011
Last Update Posted : November 5, 2020
Sponsor:
Information provided by (Responsible Party):
Sofia Ahmed, University of Calgary

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date November 5, 2020
Study Start Date  ICMJE July 2011
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
Change in filtration fraction [ Time Frame: after 2 weeks of ingestion of fructose compared to baseline value ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
change in blood pressure in response to angiotensin II challenge [ Time Frame: change after 2 weeks of fructose ingestion ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
Official Title  ICMJE Evaluation of Fructose Ingestion and the Renin Angiotensin System in Humans
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE 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

Study Arms  ICMJE
  • Experimental: Fructose First
    1. Study Day 1 - measurement of renal hemodynamics and blood pressure
    2. Subjects will ingest fructose 200g daily x 14d
    3. Study Day 2 - measurement of renal hemodynamics
    4. Minimum 1 week "washout" period
    5. Subjects will ingest dextrose 200g daily x 14d
    6. Study Day 3 - measurement of renal hemodynamics and blood pressure
    Intervention: Dietary Supplement: Fructose
  • Active Comparator: Dextrose First
    1. Study Day 1 - measurement of renal hemodynamics and blood pressure
    2. Subjects will ingest dextrose 200g daily x 14d
    3. Study Day 2 - measurement of renal hemodynamics
    4. Minimum 1 week "washout" period
    5. Subjects will ingest fructose 200g daily x 14d
    6. Study Day 3 - measurement of renal hemodynamics and blood pressure
    Intervention: Dietary Supplement: Fructose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019)
60
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2011)
30
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407627
Other Study ID Numbers  ICMJE UCalgary Sugar Study
AIHS ( Other Grant/Funding Number: Establishment Grant )
University of Calgary ( Other Grant/Funding Number: Dept of Med Developmental Fund )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sofia Ahmed, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sofia B Ahmed, MD MMSc University of Calgary
PRS Account University of Calgary
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP