Type 2 DiabetesADILANNCT01891955
Alimentation and Diabetes in Lanzarote - ADILAN: a Pilot Trial
A study testing Healthy diet A and Healthy diet B in people with Type 2 Diabetes, run by Lund University at 1 site in Spain.
Trial summary
The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Healthy diet A and Healthy diet B
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Feb 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medical diagnosis of type 2 diabetes
- Increased waist circumference (≥80 cm for women and ≥94 cm for men)
- Unaltered medical diabetes treatment since three months before start of study
- Stable weight (varied less than 5%) since three months before start of study
- HbA1c ≥6.0%
Who cannot join
- Creatinine >130 μmol/L
- Change of treatment with betablocker last 3 months
- Change of treatment with thyroid hormone substitution last 3 months
- Treatment with anticoagulant medication
- Oral or injected steroid treatment
- Elevated liver enzymes (AST, ALT, ALP, GPT > 4 times their respective upper reference value)
- Physical or psychical illness, or changes in personal circumstances that make it impossible for the patient to continue in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes
The purpose of this study is to compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other.
Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.
Read the detailed description
There is some uncertainty with respect to the optimal dietary treatment of type 2 diabetes. In addition to energy balance, macronutrient composition, dietary fiber and glycemic load, increasing evidence suggests that the direct endocrine effects of food may be important.
In this trial, the intervention is based on two diets. The healthy diet with grains and dairy is based on whole grains, low-fat dairy, fish, shellfish, fruit, vegetables, legumes, eggs, nuts and refined vegetable oils rich in monounsaturated fatty acids (this is called "healthy diet A"). The healthy diet without grains and dairy is based on fish, shellfish, lean meat, fruit, vegetables, root vegetables, eggs and nuts, but excludes grains, legumes, refined vegetable oils, dairy products and salt (this is called "healthy diet B"). Both diets were classified as very healthy using validated nutritional software, and are considered healthy regarding macronutrient composition, fiber, mineral and vitamin intake according to the official Spanish dietary guidelines. The macro and micronutrient ratios, fiber content and glycemic load in healthy diet A and healthy diet B have been set to be equal.
The goal is to include 15 patients (>18 years) with medical diagnosis of type 2 diabetes, with or without medication, and increased waist circumference (≥80 cm for women and ≥94 cm for men), to a cross-over trial during two periods of 4-weeks separated by a 6-week washout period.
Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of meals will be eaten at home according to specific directions.
The working hypothesis of this study is that food choice has beneficial effects on the control of glucose beyond macro/micronutrient composition, fiber content, glycemic load and weight loss.
This study will provide information on whether food choice and diet quality has greater impact than macro/micronutrient composition, fiber content, glycemic load and weight loss in glucose control in patients with type 2 diabetes, and the need to conduct a long-term trial testing our hypothesis.
- Conditions
- Type 2 Diabetes
- Being tested
- Healthy diet A, Healthy diet B
- Keywords
- Diabetes mellitus type 2, Cereals, Dairy, Dietary carbohydrates, Dietary fiber, Food, Metabolic syndrome, Satiety
- Medical subject headings
- Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy diet ABehavioural
Healthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called "healthy diet with grains and dairy"). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.
Healthy diet BBehavioural
Healthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called "healthy diet without grains and dairy"). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins.
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Active comparator | Healthy diet with grains and dairy Receives: Behavioral: Healthy diet A |
| Diet B | Active comparator | Healthy diet without grains and dairy Receives: Behavioral: Healthy diet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting fructosamine
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting glucagon
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Secondary outcomes (18)
Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting plasma glucose
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Total cholesterol
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Low-density lipoprotein (LDL) cholesterol
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
High-density lipoprotein (HDL) cholesterol
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Triglycerides
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Systolic and diastolic blood pressure
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
High-sensitive C-reactive protein
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Waist circumference
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Hip circumference
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Sagittal abdominal diameter
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Tricipital, bicipital, suprailiac and subscapular skinfold thickness
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Satiation measured on a likert scale at food intake during 4 consecutive days
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Quality of life using a validated spanish version of the SF-36 questionnaire
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Change in medication
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Body weight
Measured: To be assessed at baseline and after 4, 10 and 14 weeks
Fasting HbA1c
Measured: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Cabildo de Lanzarote, Ayuntamiento de Teguise, Ayuntamiento de Arrecife
- Responsible party
- Principal investigator, Maelán Fontes-Villalba, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891955
- Sponsor's protocol ID
- MFV-ADI-2013-01
- Acronym
- ADILAN
- Status last verified
- Mar 2014
- First submitted
- 28 Jun 2013
- Last updated
- 21 Mar 2014
- Results posted
- No
Publications
Nield L, Moore HJ, Hooper L, Cruickshank JK, Vyas A, Whittaker V, Summerbell CD. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004097. doi: 10.1002/14651858.CD004097.pub4.
PubMed 17636747Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.
PubMed 23364002Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
PubMed 19604407Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
PubMed 17583796Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
PubMed 16336696Fontes-Villalba M, Jonsson T, Granfeldt Y, Frassetto LA, Sundquist J, Sundquist K, Carrera-Bastos P, Fika-Hernando M, Picazo O, Lindeberg S. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN. Trials. 2014 Jan 2;15:2. doi: 10.1186/1745-6215-15-2.
PubMed 24383431
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alimentation and Diabetes in Lanzarote - ADILAN: a Randomized Cross-over Pilot Trial Comparing a Healthy Diet With Grains and Dairy to a Healthy Diet Without Grains and Dairy in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01891955
- Acronym / sponsor ID
- ADILAN / MFV-ADI-2013-01
- Conditions
- Type 2 Diabetes
- Keywords
- Diabetes mellitus type 2, Cereals, Dairy, Dietary carbohydrates, Dietary fiber, Food, Metabolic syndrome, Satiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Cabildo de Lanzarote, Ayuntamiento de Teguise, Ayuntamiento de Arrecife
- Study start
- Nov 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 3 Jul 2013 (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 compare two healthy diets (according to official Spanish guidelines) that have been shown to be effective in the treatment of type 2 diabetes in order to see if one is better than the other.
Another goal is to test the hypothesis that food choice has metabolic effects that are independent of macro/micronutrient composition, fiber content, glycemic load and weight loss in the treatment of type 2 diabetes.
Detailed description
There is some uncertainty with respect to the optimal dietary treatment of type 2 diabetes. In addition to energy balance, macronutrient composition, dietary fiber and glycemic load, increasing evidence suggests that the direct endocrine effects of food may be important.
In this trial, the intervention is based on two diets. The healthy diet with grains and dairy is based on whole grains, low-fat dairy, fish, shellfish, fruit, vegetables, legumes, eggs, nuts and refined vegetable oils rich in monounsaturated fatty acids (this is called "healthy diet A"). The healthy diet without grains and dairy is based on fish, shellfish, lean meat, fruit, vegetables, root vegetables, eggs and nuts, but excludes grains, legumes, refined vegetable oils, dairy products and salt (this is called "healthy diet B"). Both diets were classified as very healthy using validated nutritional software, and are considered healthy regarding macronutrient composition, fiber, mineral and vitamin intake according to the official Spanish dietary guidelines. The macro and micronutrient ratios, fiber content and glycemic load in healthy diet A and healthy diet B have been set to be equal.
The goal is to include 15 patients (>18 years) with medical diagnosis of type 2 diabetes, with or without medication, and increased waist circumference (≥80 cm for women and ≥94 cm for men), to a cross-over trial during two periods of 4-weeks separated by a 6-week washout period.
Lunch will be served in a hospital kitchen for control of nutrient intake, while the rest of meals will be eaten at home according to specific directions.
The working hypothesis of this study is that food choice has beneficial effects on the control of glucose beyond macro/micronutrient composition, fiber content, glycemic load and weight loss.
This study will provide information on whether food choice and diet quality has greater impact than macro/micronutrient composition, fiber content, glycemic load and weight loss in glucose control in patients with type 2 diabetes, and the need to conduct a long-term trial testing our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A | Active comparator | Behavioral: Healthy diet AHealthy diet with grains and dairy |
| Diet B | Active comparator | Behavioral: Healthy diet BHealthy diet without grains and dairy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medical diagnosis of type 2 diabetes
- Increased waist circumference (≥80 cm for women and ≥94 cm for men)
- Unaltered medical diabetes treatment since three months before start of study
- Stable weight (varied less than 5%) since three months before start of study
- HbA1c ≥6.0%
Key exclusion criteria (7 listed)
- Creatinine >130 μmol/L
- Change of treatment with betablocker last 3 months
- Change of treatment with thyroid hormone substitution last 3 months
- Treatment with anticoagulant medication
- Oral or injected steroid treatment
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 |
|---|---|---|
| Healthy diet AHealthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called "healthy diet with grains and dairy"). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins. | Behavioural | Diet A |
| Healthy diet BHealthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called "healthy diet without grains and dairy"). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins. | Behavioural | Diet B |
Primary outcome
Fasting fructosamine
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting glucagon
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
18 secondary outcomes
Area under the curve for glucose (AUC glucose0-120) at the oral glucose tolerance test
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Area under the curve for glucagon (AUC glucagon0-120) at the oral glucose tolerance test
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Fasting plasma glucose
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Total cholesterol
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Low-density lipoprotein (LDL) cholesterol
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
High-density lipoprotein (HDL) cholesterol
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Triglycerides
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Systolic and diastolic blood pressure
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
High-sensitive C-reactive protein
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
Waist circumference
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Hip circumference
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Sagittal abdominal diameter
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Tricipital, bicipital, suprailiac and subscapular skinfold thickness
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Satiation measured on a likert scale at food intake during 4 consecutive days
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Quality of life using a validated spanish version of the SF-36 questionnaire
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Change in medication
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Body weight
Time frame: To be assessed at baseline and after 4, 10 and 14 weeks
Fasting HbA1c
Time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks
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 21 Mar 2014.
- Background: PubMed 17636747Nield L, Moore HJ, Hooper L, Cruickshank JK, Vyas A, Whittaker V, Summerbell CD. Dietary advice for treatment of type 2 diabetes mellitus in adults. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD004097. doi: 10.1002/14651858.CD004097.pub4.
- Background: PubMed 23364002Ajala O, English P, Pinkney J. Systematic review and meta-analysis of different dietary approaches to the management of type 2 diabetes. Am J Clin Nutr. 2013 Mar;97(3):505-16. doi: 10.3945/ajcn.112.042457. Epub 2013 Jan 30.
- Background: PubMed 19604407Jonsson T, Granfeldt Y, Ahren B, Branell UC, Palsson G, Hansson A, Soderstrom M, Lindeberg S. Beneficial effects of a Paleolithic diet on cardiovascular risk factors in type 2 diabetes: a randomized cross-over pilot study. Cardiovasc Diabetol. 2009 Jul 16;8:35. doi: 10.1186/1475-2840-8-35.
- Background: PubMed 17583796Lindeberg S, Jonsson T, Granfeldt Y, Borgstrand E, Soffman J, Sjostrom K, Ahren B. A Palaeolithic diet improves glucose tolerance more than a Mediterranean-like diet in individuals with ischaemic heart disease. Diabetologia. 2007 Sep;50(9):1795-1807. doi: 10.1007/s00125-007-0716-y. Epub 2007 Jun 22.
- Background: PubMed 16336696Jonsson T, Olsson S, Ahren B, Bog-Hansen TC, Dole A, Lindeberg S. Agrarian diet and diseases of affluence--do evolutionary novel dietary lectins cause leptin resistance? BMC Endocr Disord. 2005 Dec 10;5:10. doi: 10.1186/1472-6823-5-10.
- Derived from this study: PubMed 24383431Fontes-Villalba M, Jonsson T, Granfeldt Y, Frassetto LA, Sundquist J, Sundquist K, Carrera-Bastos P, Fika-Hernando M, Picazo O, Lindeberg S. A healthy diet with and without cereal grains and dairy products in patients with type 2 diabetes: study protocol for a random-order cross-over pilot study--Alimentation and Diabetes in Lanzarote--ADILAN. Trials. 2014 Jan 2;15:2. doi: 10.1186/1745-6215-15-2.
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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 Healthy diet A and Healthy diet B in people with Type 2 Diabetes, run by Lund University at 1 site in Spain.
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 21 Mar 2014. 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 Spain. 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?
Fasting fructosamine (time frame: Laboratory tests will be performed at baseline and after 4, 10 and 14 weeks). The study lists 2 primary outcomes in all. 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 NCT01891955, which also lists 6 linked publications.
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 21 Mar 2014.