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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Glycemic Control Dietary Supplement: Sucrose consumption Dietary Supplement: water consumption Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
Study Start Date : March 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Sucrose

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sucrose
Sucrose
 Dietary Supplement: Sucrose consumption
Sucrose
Placebo Comparator: Water
Water
 Dietary Supplement: water consumption
water


Outcome Measures
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Primary Outcome Measures :
  1. Hyperglycemia [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. Hyperglycemia [ Time Frame: Postprandially ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00821665


Locations
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Netherlands
Maastricht University
Maastricht, Limbrug, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University Medical Center
Suikerstichting Nederland (Baarn)
Investigators
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Principal Investigator: Luc J van Loon, Ph.D Maastricht University
More Information
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Responsible Party: Dr. L.J.C. van Loon Ph.D, Maastricht University
ClinicalTrials.gov Identifier: NCT00821665    
Other Study ID Numbers: 07-3-004
First Posted: January 13, 2009    Key Record Dates
Last Update Posted: January 13, 2009
Last Verified: January 2009
Keywords provided by Maastricht University Medical Center:
Type 2 diabetes
Glycemic control
(postprandial) Hyperglycemia
Sucrose
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases