Type 2 DiabetesNCT00821665
Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
A study testing Sucrose consumption and water consumption in people with Type 2 Diabetes and Glycemic Control, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Glycemic Control
- What is being tested?
- Sucrose consumption and water consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lean NGT Group
- Normoglycemic (according to 2006 ADA guidelines)
- BMI < 27 kg/m2
- Obese NGT Group
- Normoglycemic
- BMI 30- 35 kg/m2
Show all 9Show fewer
- Obese type 2 diabetes Group
- BMI 30- 35 kg/m2
- Oral blood glucose lowering medication
Who cannot join
- Exogenous insulin use
- Cardiac disease (any cardiac event in the last 5 years)
- HbA1c >10%
- Microalbuminuria: albumin:creatinine ratio >2,5
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Type 2 Diabetes, Glycemic Control
- Being tested
- Sucrose consumption, water consumption
- Keywords
- Type 2 diabetes, Glycemic control, (postprandial) Hyperglycemia, Sucrose
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sucrose consumptionDietary supplement
Sucrose
water consumptionDietary supplement
water
| Study group | Role | What they receive |
|---|---|---|
| Sucrose | Experimental | Sucrose Receives: Dietary Supplement: Sucrose consumption |
| Water | Placebo comparator | Water Receives: Dietary Supplement: water consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperglycemia
Measured: 24h
Secondary outcomes (1)
Hyperglycemia
Measured: Postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Suikerstichting Nederland (Baarn)
- Investigators
- Luc J van Loon, Ph.D, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821665
- Sponsor's protocol ID
- 07-3-004
- Status last verified
- Jan 2009
- First submitted
- 12 Jan 2009
- Last updated
- 13 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Glucose Homeostasis in Type 2 Diabetes: the Effects of Saccharose
- ClinicalTrials.gov ID
- NCT00821665
- Acronym / sponsor ID
- 07-3-004
- Conditions
- Type 2 Diabetes, Glycemic Control
- Keywords
- Type 2 diabetes, Glycemic control, (postprandial) Hyperglycemia, Sucrose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Suikerstichting Nederland (Baarn)
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sucrose | Experimental | Dietary Supplement: Sucrose consumptionSucrose |
| Water | Placebo comparator | Dietary Supplement: water consumptionWater |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Lean NGT Group
- Normoglycemic (according to 2006 ADA guidelines)
- BMI < 27 kg/m2
- Obese NGT Group
- Normoglycemic
Key exclusion criteria (4 listed)
- Exogenous insulin use
- Cardiac disease (any cardiac event in the last 5 years)
- HbA1c >10%
- Microalbuminuria: albumin:creatinine ratio >2,5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sucrose consumptionSucrose | Dietary supplement | Sucrose |
| water consumptionwater | Dietary supplement | Water |
Primary outcome
Hyperglycemia
Time frame: 24h
1 secondary outcome
Hyperglycemia
Time frame: Postprandially
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc J van Loon, Ph.D principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sucrose consumption and water consumption in people with Type 2 Diabetes and Glycemic Control, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperglycemia (time frame: 24h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2009.