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

January 12, 2009 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Water
Dietary supplement: water consumption
water
Experimental: Sucrose
Dietary supplement: Sucrose consumption
Sucrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hyperglycemia
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Time Frame
Hyperglycemia
Time Frame: Postprandially
Postprandially

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Suikerstichting Nederland (Baarn)

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 13, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2009

Last Update Submitted That Met QC Criteria

January 12, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-3-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe