Diabetes Mellitus, Type 1Phase 3LGID1NCT01184703
Low Glycemic Index Diet in Patients With Type 1 Diabetes
A Phase 3 study testing Low GI food in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Low GI food
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2007to Dec 2009
- Phase
- Phase 3
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I diabetes, durability >5 years
- Age 20-65 years
- Normal weight (BMI 19-26 kg/m2)
- Diabetic treatment with mealtime and bedtime insulin.
- HbA1c ≤10 %
- Informed consent to participate in the study.
Who cannot join
- Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
- A known food intolerance of gluten, leguminous plants, nuts or almonds.
- Pregnancy or breast-feeding.
- Concurrent participation in another research study with metabolic effects.
- Previously regular follow-up with a dietician at SDC during the last year.
- Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
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- Non acceptance of the study diet or food products that are recommended in the study.
- Disability to read and understand the Danish language.
- Unable to receive and/or store the test products.
- Place of residence >1 hr drive from SDC.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes
The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.
Read the detailed description
The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future.
Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Low GI food
- Keywords
- Diabetes Mellitus, Type 1, Glycemic Index Diet, HbA1c, Lipids
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low GI foodOther
Comparison of carbohydrates in diabetic patients
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Secondary outcomes (1)
LDL-cholesterol
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Margareta Bensow Bacos, Ch Diet, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184703
- Sponsor's protocol ID
- GI-project_1
- Acronym
- LGID1
- Status last verified
- Aug 2010
- First submitted
- 17 Aug 2010
- Last updated
- 6 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes
- ClinicalTrials.gov ID
- NCT01184703
- Acronym / sponsor ID
- LGID1 / GI-project_1
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Glycemic Index Diet, HbA1c, Lipids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 19 Aug 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 purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.
Detailed description
The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future.
Comparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type I diabetes, durability >5 years
- Age 20-65 years
- Normal weight (BMI 19-26 kg/m2)
- Diabetic treatment with mealtime and bedtime insulin.
- HbA1c ≤10 %
Key exclusion criteria (10 listed)
- Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
- A known food intolerance of gluten, leguminous plants, nuts or almonds.
- Pregnancy or breast-feeding.
- Concurrent participation in another research study with metabolic effects.
- Previously regular follow-up with a dietician at SDC during the last year.
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 |
|---|---|---|
| Low GI foodComparison of carbohydrates in diabetic patients | Other | – |
Primary outcome
HbA1c
Time frame: 3 months
1 secondary outcome
LDL-cholesterol
Time frame: 3 months
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 6 Sep 2010.
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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.
Margareta Bensow Bacos, Ch Diet principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low GI food in people with Diabetes Mellitus, Type 1, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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 6 inclusion and 10 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 6 Sep 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 Denmark. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
HbA1c (time frame: 3 months). 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 6 Sep 2010.