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

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

Tracking Information

• First Submitted Date: January 12, 2009
• First Posted Date: January 13, 2009
• Last Update Posted Date: January 13, 2009
• Study Start Date: March 2007
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 12, 2009): Hyperglycemia [ Time Frame: 24h ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: January 12, 2009): Hyperglycemia [ Time Frame: Postprandially ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Basic Science

Condition

• Type 2 Diabetes
• Glycemic Control

Intervention

• Dietary Supplement: Sucrose consumption
  Sucrose
• Dietary Supplement: water consumption
  water

Study Arms

• Experimental: Sucrose
  Sucrose
  Intervention: Dietary Supplement: Sucrose consumption
• Placebo Comparator: Water
  Water
  Intervention: Dietary Supplement: water consumption

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 12, 2009): 39
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: September 2008
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 40 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT00821665
• Other Study ID Numbers: 07-3-004
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. L.J.C. van Loon Ph.D, Maastricht University
• Study Sponsor: Maastricht University Medical Center
• Collaborators: Suikerstichting Nederland (Baarn)

Investigators

• Principal Investigator: Luc J van Loon, Ph.D; Maastricht University

• PRS Account: Maastricht University Medical Center
• Verification Date: January 2009