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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00821665
• Other study ID #: 07-3-004
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: January 12, 2009
• Start date: March 2007
• Est. completion date: September 2008

Study information

• Verified date: January 2009
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Glycemic Control
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Sucrose consumption
Sucrose
• water consumption
water

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht	Limbrug

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Suikerstichting Nederland (Baarn)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperglycemia		24h	No
Secondary	Hyperglycemia		Postprandially	No