Type 2 DiabetesNCT00767208
Diabetes and Metabolic Postprandial Responses
A study testing oral glucose load in people with Type 2 Diabetes and Overweight, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
Trial summary
The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight
- What is being tested?
- oral glucose load
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to May 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight or obese volunteers
- Healthy for one group nd type 2 diabetic for the second group
- Age between 30 and 65 years old
- Total cholesterol < or = 7 mmol/l and triglycerides < or = 4 mmol/l
- For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c < 6%
- Stable weight over last 3 months
- Informed consent
Who cannot join
- No compliant subjects
- Participation in an other trial 2 months before starting this one
- Ward of court or under guardianship (sheltered adults)
- Person deprived of freedom by judicial or administrative decision
- Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose
- Existence of a previously diagnosed pathology (other than type 2 diabetes)
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- Previous gastro-intestinal pathology
- Treated by corticoids, anorexigens, weight loss medicines
- Alcoholism or severe tobacco consumption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects
The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.
- Conditions
- Type 2 Diabetes, Overweight
- Being tested
- oral glucose load
- Keywords
- type 2 diabetic subjects
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral glucose loadOther
oral ingestion of 13C labeled glucose
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetic subjects | Experimental | Not described Receives: Other: oral glucose load |
| overweight healthy subjects | Experimental | Not described Receives: Other: oral glucose load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism
Measured: 6 hours postprandially
Secondary outcomes (2)
Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides
Measured: 6 hours postprandially
Carbohydrate and lipid oxidation
Measured: 6 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startJan 2005
- Primary completionMay 2006
- Study completionMay 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.
- 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-Alpe
- Sponsor type
- University, hospital or other
- Collaborators
- LESAFFRE SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767208
- Sponsor's protocol ID
- CRNHRA-06-002
- Status last verified
- May 2009
- First submitted
- 6 Oct 2008
- Last updated
- 20 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postprandial Metabolic Responses Between Type 2 Diabetic and Healthy Overweight Subjects
- ClinicalTrials.gov ID
- NCT00767208
- Acronym / sponsor ID
- CRNHRA-06-002
- Conditions
- Type 2 Diabetes, Overweight
- Keywords
- type 2 diabetic subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Centre de Recherche en Nutrition Humaine Rhone-AlpeUniversity, hospital or other
- Collaborators
- LESAFFRE SA
- Study start
- Jan 2005
- Primary completion
- May 2006 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 7 Oct 2008 (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.
The aim of this trial was to compare postprandial metabolic response to glucose load in healthy overweight and type 2 diabetic subjects, by using glycemia, insulinemia, lipid profile, nutrient oxidation follow-up. Stable isotopes of glucose were used to assess postprandial total,exogenous and endogenous glucose kinetics.
Study design
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetic subjects | Experimental | Other: oral glucose load |
| overweight healthy subjects | Experimental | Other: oral glucose load |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Overweight or obese volunteers
- Healthy for one group nd type 2 diabetic for the second group
- Age between 30 and 65 years old
- Total cholesterol < or = 7 mmol/l and triglycerides < or = 4 mmol/l
- For diabetic group: treated by metformin and/or sulfonylurea and/or thiazolidinedione and HbA1c < 6%
Key exclusion criteria (9 listed)
- No compliant subjects
- Participation in an other trial 2 months before starting this one
- Ward of court or under guardianship (sheltered adults)
- Person deprived of freedom by judicial or administrative decision
- Type 1 diabetes and type 2 diabetes treated bu insulin or acarbose
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 |
|---|---|---|
| oral glucose loadoral ingestion of 13C labeled glucose | Other | overweight healthy subjects, type 2 diabetic subjects |
Primary outcome
Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism
Time frame: 6 hours postprandially
2 secondary outcomes
Postprandial concentrations of glucose, non esterified fatty acids, insulin and triglycerides
Time frame: 6 hours postprandially
Carbohydrate and lipid oxidation
Time frame: 6 hours 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 20 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral glucose load in people with Type 2 Diabetes and Overweight, run by Centre de Recherche en Nutrition Humaine Rhone-Alpe at 1 site in France.
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 7 inclusion and 9 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 20 May 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 France. 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. 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?
Apparition of exogenous glucose in plasma in the postprandial phase and its effect on carbohydrate and lipid metabolism (time frame: 6 hours postprandially). 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 20 May 2009.