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

This study has been completed.

First Received: January 12, 2009 No Changes Posted

Sponsors and Collaborators:	Maastricht University Medical Center Suikerstichting Nederland (Baarn)
Information provided by:	Maastricht University Medical Center
ClinicalTrials.gov Identifier:	NCT00821665

Purpose

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	Intervention
Type 2 Diabetes Glycemic Control	Dietary Supplement: Sucrose consumption Dietary Supplement: water consumption

MedlinePlus related topics: Diabetes Dietary Supplements Diets Drinking Water

Drug Information available for: Sucrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Official Title:	Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:

Hyperglycemia [ Time Frame: 24h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hyperglycemia [ Time Frame: Postprandially ] [ Designated as safety issue: No ]

Enrollment:	39
Study Start Date:	March 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sucrose: Experimental Sucrose	Dietary Supplement: Sucrose consumption Sucrose
Water: Placebo Comparator Water	Dietary Supplement: water consumption water

Eligibility

Ages Eligible for Study:	40 Years to 60 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821665

Locations

Netherlands, Limbrug
Maastricht University
Maastricht, Limbrug, Netherlands, 6200 MD

Sponsors and Collaborators

Maastricht University Medical Center

Suikerstichting Nederland (Baarn)

Investigators

Principal Investigator:

Luc J van Loon, Ph.D

Maastricht University Medical Center

More Information

No publications provided

Responsible Party:	Maastricht University ( Dr. L.J.C. van Loon Ph.D )
Study ID Numbers:	07-3-004
Study First Received:	January 12, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821665 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:

Type 2 diabetes
Glycemic control
(postprandial) Hyperglycemia
Sucrose

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009