Type 2 DiabetesPhase 1/2NCT01070238
Metabolic Response of Slow Released Carbohydrates in Diabetes Mellitus
A Phase 1/2 study testing Isomaltulose in people with Type 2 Diabetes, run by University of Giessen at 1 site in Germany.
Trial summary
The study was conducted 1. to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia 2. to describe the kinetics of glucose absorption after a load of isomaltulose 3. to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Isomaltulose
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis: type 2 diabetes according to WHO/ADA criteria for more than 1 yr
- Adults aged 18-75 years old
- HbA1c < 8%, fasting blood glucose < 140 mg/dl
- For at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen
- Subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements
Who cannot join
- Type 1 diabetes mellitus
- Pregnant or lactating women or women planning to become pregnant
- Women who become pregnant will be withdrawn from the study
- Clinically significant heart, liver, lung, or kidney disease
- Drug or alcohol abuse
- Concomitant therapy with systemic glucocorticoids or acarbose
- Subjects unable to adhere to instructions during the qualification phase
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients
The study was conducted
- to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia
- to describe the kinetics of glucose absorption after a load of isomaltulose
- to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.
Read the detailed description
Epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. An effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. It is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2.
Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. This study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.
- Conditions
- Type 2 Diabetes
- Being tested
- Isomaltulose
- Keywords
- Isomaltulose, Slow Released Carbohydrates, Postprandial Glucose Metabolism, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Collaborators
- Numico Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070238
- Sponsor's protocol ID
- RA.4240.UKGiessen.021219.B
- Status last verified
- Nov 2002
- First submitted
- 16 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Ang M, Linn T. Comparison of the effects of slowly and rapidly absorbed carbohydrates on postprandial glucose metabolism in type 2 diabetes mellitus patients: a randomized trial. Am J Clin Nutr. 2014 Oct;100(4):1059-68. doi: 10.3945/ajcn.113.076638. Epub 2014 Jul 16.
PubMed 25030779
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative, Pilot Study With Cross-over Design on the Metabolic Response of Orally Applied Slow Released Carbohydrates in Diabetes Type 2 Patients
- ClinicalTrials.gov ID
- NCT01070238
- Acronym / sponsor ID
- RA.4240.UKGiessen.021219.B
- Conditions
- Type 2 Diabetes
- Keywords
- Isomaltulose, Slow Released Carbohydrates, Postprandial Glucose Metabolism, Type 2 diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Collaborators
- Numico Research
- First posted
- 17 Feb 2010 (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 study was conducted
- to investigate the superiority of isomaltulose in reduction of postprandial hyperglycemia
- to describe the kinetics of glucose absorption after a load of isomaltulose
- to demonstrate the safety of a single load of isomaltulose compared to sucrose in type 2 diabetic patients.
Detailed description
Epidemiological studies have shown that postprandial hyperglycemia is associated with atherosclerotic diseases. Therefore, therapeutic strategies to reduce postprandial hyperglycemia are desirable. An effective way to improve postprandial glucose level is the use of carbohydrates with low glycemic index. Isomaltulose is a reducing disaccharide occurring naturally in honey and sugar cane juice, including products derived thereof. It is an isomer of sucrose and composed of glucose and fructose linked alpha-1,6 instead of alpha-1,2.
Isomaltulose has been reported to be digested more slowly than sucrose. Due to this property, lower and slower increases in blood glucose responses are expected for isomaltulose than sucrose. Early studies have demonstrated attenuated glycemic and insulin responses after isomaltulose ingestion than after sucrose. This study was performed to describe the postprandial glucose metabolism more comprehensively after bolus administration of different doses of isomaltulose compared to sucrose in type 2 diabetic patients.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis: type 2 diabetes according to WHO/ADA criteria for more than 1 yr
- Adults aged 18-75 years old
- HbA1c < 8%, fasting blood glucose < 140 mg/dl
- For at least 2 months prior to visit 1, subjects must have been on a stable antidiabetic therapy regimen
- Subjects willing to perform home blood glucose monitoring and to otherwise comply with study protocol requirements
Key exclusion criteria (7 listed)
- Type 1 diabetes mellitus
- Pregnant or lactating women or women planning to become pregnant
- Women who become pregnant will be withdrawn from the study
- Clinically significant heart, liver, lung, or kidney disease
- Drug or alcohol abuse
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 |
|---|---|---|
| Isomaltulose | Dietary supplement | – |
Primary outcome
Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose
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 17 Feb 2010.
- Derived from this study: PubMed 25030779Ang M, Linn T. Comparison of the effects of slowly and rapidly absorbed carbohydrates on postprandial glucose metabolism in type 2 diabetes mellitus patients: a randomized trial. Am J Clin Nutr. 2014 Oct;100(4):1059-68. doi: 10.3945/ajcn.113.076638. Epub 2014 Jul 16.
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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 Phase 1/2 study testing Isomaltulose in people with Type 2 Diabetes, run by University of Giessen at 1 site in Germany.
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 5 inclusion and 7 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 17 Feb 2010. 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 Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Lower postprandial glucose and insulin responses after isomaltulose ingestion than after sucrose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01070238, which also lists 1 linked publication.
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 17 Feb 2010.