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

Primary Purpose

Type 2 Diabetes, Glycemic Control

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Sucrose consumption
water consumption
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Glycemic control, (postprandial) Hyperglycemia, Sucrose

Eligibility Criteria

40 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Maastricht University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sucrose

Water

Arm Description

Sucrose

Water

Outcomes

Primary Outcome Measures

Hyperglycemia

Secondary Outcome Measures

Hyperglycemia

Full Information

First Posted
January 12, 2009
Last Updated
January 12, 2009
Sponsor
Maastricht University Medical Center
Collaborators
Suikerstichting Nederland (Baarn)
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1. Study Identification

Unique Protocol Identification Number
NCT00821665
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
Suikerstichting Nederland (Baarn)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Glycemic Control
Keywords
Type 2 diabetes, Glycemic control, (postprandial) Hyperglycemia, Sucrose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sucrose
Arm Type
Experimental
Arm Description
Sucrose
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
Water
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose consumption
Intervention Description
Sucrose
Intervention Type
Dietary Supplement
Intervention Name(s)
water consumption
Intervention Description
water
Primary Outcome Measure Information:
Title
Hyperglycemia
Time Frame
24h
Secondary Outcome Measure Information:
Title
Hyperglycemia
Time Frame
Postprandially

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc J van Loon, Ph.D
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University
City
Maastricht
State/Province
Limbrug
ZIP/Postal Code
6200 MD
Country
Netherlands

12. IPD Sharing Statement

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

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