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Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

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ClinicalTrials.gov Identifier: NCT00821665
Recruitment Status : Completed
First Posted : January 13, 2009
Last Update Posted : January 13, 2009
Sponsor:
Collaborator:
Suikerstichting Nederland (Baarn)
Information provided by:
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE January 12, 2009
First Posted Date  ICMJE January 13, 2009
Last Update Posted Date January 13, 2009
Study Start Date  ICMJE March 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Hyperglycemia [ Time Frame: 24h ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
Hyperglycemia [ Time Frame: Postprandially ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Official Title  ICMJE Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Brief Summary

Hyperglycemia forms a direct and independent risk factor for the development of cardiovascular co-morbidities in type 2 diabetes. Consumption of sucrose-sweetened soft drinks might further increase the prevalence of hyperglycemic episodes.

The objective of the study was to assess glycemic control in type 2 diabetes patients and healthy lean and obese controls under strict dietary standardization but otherwise free living conditions, with and without the consumption of soft drinks.

Detailed Description Not Provided
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: Basic Science
Condition  ICMJE
  • Type 2 Diabetes
  • Glycemic Control
Intervention  ICMJE
  • Dietary Supplement: Sucrose consumption
    Sucrose
  • Dietary Supplement: water consumption
    water
Study Arms  ICMJE
  • Experimental: Sucrose
    Sucrose
    Intervention: Dietary Supplement: Sucrose consumption
  • Placebo Comparator: Water
    Water
    Intervention: Dietary Supplement: water consumption
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 Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Lean NGT Group

  • Normoglycemic (according to 2006 ADA guidelines)
  • BMI < 27 kg/m2

Obese NGT Group

  • Normoglycemic
  • BMI 30- 35 kg/m2

Obese type 2 diabetes Group

  • BMI 30- 35 kg/m2
  • Oral blood glucose lowering medication

Exclusion Criteria:

  • Exogenous insulin use
  • Cardiac disease (any cardiac event in the last 5 years)
  • HbA1c >10%
  • Microalbuminuria: albumin:creatinine ratio >2,5
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00821665
Other Study ID Numbers  ICMJE 07-3-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. L.J.C. van Loon Ph.D, Maastricht University
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Suikerstichting Nederland (Baarn)
Investigators  ICMJE
Principal Investigator: Luc J van Loon, Ph.D Maastricht University
PRS Account Maastricht University Medical Center
Verification Date January 2009

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