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Effect of Acute Fructose Load in Human

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Neda Rajamand Ekberg, Karolinska University Hospital
Sponsor:
Information provided by (Responsible Party):
Neda Rajamand Ekberg, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT03157960
First received: May 16, 2017
Last updated: NA
Last verified: May 2017
History: No changes posted
  Purpose
The metabolism of the monosaccharide fructose is less controlled than the metabolism of glucose, which will result in the metabolic product uric acid. Elevated serum uric acid levels are associated with increased risk, or worsening, of chronic kidney disease. The mechanisms by which uric acid have detrimental effects are not well defined, but may include an increase in reactive oxygen species and subsequent inflammatory activity. The aim of this study is to investigate the effects of uric acid, markers of oxidative stress and markers of inflammation following a low fructose load reflecting normal conditions. This is an interventional study. On six different occasions patients with chronic kidney disease, patients with type 2 diabetes and healthy controls will receive Blueberry drink, Coca-Cola or pure Fructose drink with similar amount of carbohydrates (140 kcal) with and without a high fat meal represented by a pizza (425 kcal).Serum samples and urinary samples will be collected.

Condition Intervention
Chronic Kidney Diseases Diabetes Mellitus, Type 2 Other: Blueberry drink Other: Blueberry and pizza Other: Soft beverage Other: Soft beverage and pizza Other: Fructose Other: Fructose and pizza

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Interventional study. Participant will on sex different occasions receive drinks containing fructose (fructose drink, coca-cola or blueberry drink) with and without the addition of a high-fat meal
Masking: No masking
Primary Purpose: Basic Science
Official Title: The Effect of Acute Fructose Load in Patients With Chronic Kidney Disease and Patients With Type 2 Diabetes Compared to Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Neda Rajamand Ekberg, Karolinska University Hospital:

Primary Outcome Measures:
  • Changes in uric acid (µmol/L) [ Time Frame: 2 hours for only drink and 4 hours for drink and a high fat meal ]
    Change in uric acid after intervention compared to the levels Before the intervention


Estimated Enrollment: 120
Actual Study Start Date: February 1, 2012
Estimated Study Completion Date: November 30, 2019
Estimated Primary Completion Date: November 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blueberry drink
Participant will receive a blueberry drink containing 18 g of fructose and 14 g of glucose.
Other: Blueberry drink
Participant receive blueberry drink
Experimental: Blueberry and pizza
Participant will receive a blueberry drink and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)
Other: Blueberry and pizza
Participant receive blueberry drink and a slice of pizza
Experimental: Soft beverage
Participant will receive a Soft beverage (Coca-cola containing 17,5 g fructose and 17,5 g glucose)
Other: Soft beverage
Participant receive a soft beverage drink
Experimental: Soft beverage and pizza
Participant will receive a Soft beverage and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)
Other: Soft beverage and pizza
Participant receive a soft beverage drink and a slice of pizza
Experimental: Fructose
Participant will receive a drink containing 35 g of fructose
Other: Fructose
Participant receive a drink containing fructose
Experimental: Fructose and pizza
Participant will receive a drink containing 35 g of fructose and a slice of pizza (170 grams; 22 g protein, 20 g fat and 50 g carbohydrate; 425 kCal)
Other: Fructose and pizza
Participant receive a fructose drink and a slice of pizza

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • GFR <30 ml/min or >3 months of dialysis for patients with CKD
  • Patients with type 2 diabetes with and without CKD
  • Controls without diabetes type 2 or CKD

Exclusion Criteria:

  • HbA1c > 100 mmol/mol.
  • Signs of fluid overload
  • Inability to understand the information provided for the study.
  • Ongoing inflammatory disease or infection,
  • Treatment with allopurinol or other uric acid lowering agents a
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03157960

Contacts
Contact: Neda Rajamand Ekberg, M.D./Ph.D +46851773796 neda.ekberg@ki.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Neda R Ekberg, M.D./Ph.D.    +46-51770000    neda.ekberg@ki.se   
Sponsors and Collaborators
Karolinska University Hospital
Investigators
Study Director: Peter Stenvinkel, professor Karolinska University Hospital
  More Information

Publications:

Responsible Party: Neda Rajamand Ekberg, M.D.,Ph.D, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT03157960     History of Changes
Other Study ID Numbers: 2011/1183-31/2
Study First Received: May 16, 2017
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neda Rajamand Ekberg, Karolinska University Hospital:
Fructose
Uric acid
Oxidised LDL
Interleukin 6

Additional relevant MeSH terms:
Diabetes Mellitus
Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on August 16, 2017