Type2 DiabetesNCT03289494
Evaluation of 2 Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile, in T2D Patients
A study testing Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in people with Type2 Diabetes, run by Mondelēz International, Inc. at 1 site in France.
Trial summary
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2017to 24 Jul 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient able to understand the study information and providing written consents for his/her participation to the study
- Male or female
- Patient undergoing medical examination during the selection visit
- Patient aged between 18 and 75 years old (bounds included)
- T2D volunteer with:
- HbA1c between 6,5% and 8,5%
Show all 17Show fewer
- Bi-therapy associating metformin and sitagliptin at stable dose for at least 1 month
- T2D volunteer without insulin therapy or GLP-1 analogues
- Patient with BMI ranging between 22 and 37 kg/m2 (bounds included)
- Patient with stable body weight over the past three months (+/- 5 % of body weight)
- Patient accepting to change its diet for two weeks
- Patient not suffering from intolerance or allergy
- Patient regularly consuming products proposed in the study
- Patient regularly consuming 3 main meals per day
- Sedentary behavior or stable regular physical activity during the study
- Patient not presenting any disease during the medical examination / interview which could interfere with the results of the study according to the investigator
- Patient covered by health assurance
Who cannot join
- General criteria:
- Patient under legal protection measure
- Patient deprived of liberty by a court or an administrative decision
- Patient currently participating in another study or being in the exclusion period of another study
- Volunteer that exceed the financial compensation allowed per year for participating in research programs
- Biological criteria:
Show all 31Show fewer
- Gamma-GT > 2.5 times above the norm (>160 UI/L)
- ASAT > 2.5 times above the norm (>85 UI/L)
- ALAT > 2.5 times above the norm (>137.5 UI/L)
- Triglycerides > 4 g/L
- LDL-cholesterol > 1.90 g/L
- CRP > 15 mg/L
- Hemoglobin < 120 mg/dL
- Other biological abnormality with clinical significant relevance according to the investigator
- Therapeutic and medical criteria:
- Patient with type 1 diabetes
- T2D treatment other than metformin and sitagliptin
- Patient with past bariatric surgery
- Patient with medical history of endocrine diseases who may interfere with glucose metabolism according to the investigator (such as thyroid dysfunction, acromegaly, hypercorticism…)
- Uncontrolled high blood pressure defined by Systolic blood pressure > 150 mmHg or Diastolic blood pressure > 100 mmHg
- Evidence of any other unstable or untreated clinically significant immunological, neoplasic, endocrine, haematological, gastrointestinal, hepatic, neurological or psychiatric abnormalities or medical disease according to the investigator
- Pregnant women or willing to become pregnant or lactating women
- Women of childbearing age without an efficient contraceptive method according to the investigator
- Patient under a restrictive diet or willing to lose weight
- Patient with eating disorders (e.g. anorexia nervosa and bulimia) according to the investigator
- Patient without stable dietary habits or with specific diet (vegetarian, vegan,…) according to the investigator
- Patient who smokes
- Patient regularly consuming more than 20 g/day of alcohol. Consumption of more than 3 alcoholic beverages per day is recognized as excessive. An alcoholic beverage is: 30 mL of spirituous, 120 mL of wine or 330 mL of beer
- Patient regularly consuming recreational drugs
- Patient consuming in the two previous months regularly corticoids, anorectics, adrenergic drugs, beta-blocking drugs, antiplatelet agent (like aspirin) or other drugs or supplement that should impact glucose metabolism (other than metformin or DPP4 inhibitor) in the investigator's opinion
- Adhesive plaster skin allergy
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Pierre-Bénite, 69310
About this study
Official title: A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
Read the detailed description
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
8 patients with type 2 diabetic patients will be recruited.
Subjets will have 5 visits:
The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.
The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.
During each day of the first experimental diet period, the patient will take at least four blood glucometer readings per day, and will consume the food products according to a menu plan and the cooking instruction sheets given by the dietician, and fill a dietary record.
After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS, bring back the glucometer and the follow-up LogBook. A Medical check-up will also be performed. Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by each patient to have a global assessment of the diet and to evaluate the feasibility of this type of diet over longer periods.
The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook and diet specific information for the second period. The glucometer and starchy foods and cereal products will be supplied to the patients.
During each day of this second diet period, patients will be required to consume starchy foods and cereal products according to a menu plan and cooking instructions provided by the dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose control and will fill the information required in the LogBook.
Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by patients.
- Conditions
- Type2 Diabetes
- Being tested
- Balanced diet high in Slowly Digestible Starch, Balanced diet low in Slowly Digestible Starch
- Keywords
- Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS
- 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.
Balanced diet high in Slowly Digestible StarchOther
The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
Balanced diet low in Slowly Digestible StarchOther
The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Active comparator | Balanced diet high in Slowly Digestible Starch Receives: Other: Balanced diet high in Slowly Digestible Starch |
| Diet B | Placebo comparator | Balanced diet low in Slowly Digestible Starch Receives: Other: Balanced diet low in Slowly Digestible Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.
Measured: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record
Secondary outcomes (20)
Glycemic profile parameters: Minimum glycaemia
Minimum glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: maximum glycaemia
maximum glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia
Standard Deviation (SD) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia
Coefficient of Variation (CV) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MAGE
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MODDs
Mean Of Daily Differences (MODDs) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MIME
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Time in Range
Mean time spent in the appropriate glycemic range in %
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: ADRR
Average of Daily Risk Ratio (ADRR) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: CONGA
Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hyperglycemia durations
hyperglycemia durations
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hypoglycemia durations
hypoglycemia durations
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: mean glycemic value
mean glycemic value on relevant time interval
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: incremental AUC
incremental AUC calculated on relevant time interval
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: total AUC
total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: kinetics
Daylong glycaemia kinetics
Measured: minimum 3 days to a maximum of 6 days of CGMS record
Compliance parameters: mean SDS ingestion
mean SDS ingestion by type of meal and per day
Measured: maximum of 6 days of LogBook record
Dietary intake evaluation
Dietary record analysis, in g of macronutrient intake
Measured: After 1 week intervention diet
Dietary record evaluation
Dietary record analysis, in % of total energy intake
Measured: After 1 week intervention diet
Charaterisation of acceptability to H-SDS diet in free living conditions
Feedback questionnaire
Measured: After 1 week intervention diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start30 Aug 2017
- Primary completion24 Jul 2018
- Study completion24 Jul 2018
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 Type2 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each subject will receive two independant weeks of diet intervention, in a crossover design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mondelēz International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Biofortis Mérieux NutriSciences
- Responsible party
- Sponsor
- Investigators
- Emmanuel DISSE, MD, PhD, Principal investigator, Centre de Recherche en Nutrition Humaine Rhone-AlpeMartine LAVILLE, MD, PhD, Study chair, Centre de Recherche en Nutrition Humaine Rhone-Alpe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289494
- Sponsor's protocol ID
- KBE052
- Status last verified
- May 2020
- First submitted
- 13 Sep 2017
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.
PubMed 32988721
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Evaluating the Effect of Two Diets With Different Starch Digestibility Profiles on Daily Glycemic Profile Measured by Continuous Glucose Monitoring System (CGMS), in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03289494
- Acronym / sponsor ID
- KBE052
- Conditions
- Type2 Diabetes
- Keywords
- Slowly Digestible Starch, SDS, Type 2 diabetes, T2D, Glycemic response, Continuous Glucose Monitoring System, CGMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mondelēz International, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Centre de Recherche en Nutrition Humaine Rhone-Alpe, Biofortis Mérieux NutriSciences
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 24 Jul 2018 (actual)
- Study completion
- 24 Jul 2018 (actual)
- First posted
- 21 Sep 2017 (actual)
- 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 is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
Detailed description
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
8 patients with type 2 diabetic patients will be recruited.
Subjets will have 5 visits:
The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.
The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.
During each day of the first experimental diet period, the patient will take at least four blood glucometer readings per day, and will consume the food products according to a menu plan and the cooking instruction sheets given by the dietician, and fill a dietary record.
After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS, bring back the glucometer and the follow-up LogBook. A Medical check-up will also be performed. Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by each patient to have a global assessment of the diet and to evaluate the feasibility of this type of diet over longer periods.
The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook and diet specific information for the second period. The glucometer and starchy foods and cereal products will be supplied to the patients.
During each day of this second diet period, patients will be required to consume starchy foods and cereal products according to a menu plan and cooking instructions provided by the dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose control and will fill the information required in the LogBook.
Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Each subject will receive two independant weeks of diet intervention, in a crossover design
| Arm | Type | Receives |
|---|---|---|
| Diet A | Active comparator | Other: Balanced diet high in Slowly Digestible StarchBalanced diet high in Slowly Digestible Starch |
| Diet B | Placebo comparator | Other: Balanced diet low in Slowly Digestible StarchBalanced diet low in Slowly Digestible Starch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patient able to understand the study information and providing written consents for his/her participation to the study
- Male or female
- Patient undergoing medical examination during the selection visit
- Patient aged between 18 and 75 years old (bounds included)
- T2D volunteer with:
Key exclusion criteria (31 listed)
- General criteria:
- Biological criteria:
- Therapeutic and medical criteria:
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 |
|---|---|---|
| Balanced diet high in Slowly Digestible StarchThe carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week. | Other | Diet A |
| Balanced diet low in Slowly Digestible StarchThe carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week. | Other | Diet B |
Primary outcome
Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
Time frame: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record
The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.
20 secondary outcomes
Glycemic profile parameters: Minimum glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: maximum glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MAGE
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MODDs
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MIME
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Time in Range
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: ADRR
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: CONGA
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hyperglycemia durations
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hypoglycemia durations
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: mean glycemic value
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: incremental AUC
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: total AUC
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: kinetics
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Compliance parameters: mean SDS ingestion
Time frame: maximum of 6 days of LogBook record
Dietary intake evaluation
Time frame: After 1 week intervention diet
Dietary record evaluation
Time frame: After 1 week intervention diet
Charaterisation of acceptability to H-SDS diet in free living conditions
Time frame: After 1 week intervention diet
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 27 May 2020.
- Derived from this study: PubMed 32988721Breyton AE, Goux A, Lambert-Porcheron S, Meynier A, Sothier M, VanDenBerghe L, Brack O, Disse E, Laville M, Vinoy S, Nazare JA. Starch digestibility modulation significantly improves glycemic variability in type 2 diabetic subjects: A pilot study. Nutr Metab Cardiovasc Dis. 2021 Jan 4;31(1):237-246. doi: 10.1016/j.numecd.2020.08.010. Epub 2020 Aug 25.
- Individual participant dataSharing planned: No
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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.
Emmanuel DISSE, MD, PhD principal investigator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Martine LAVILLE, MD, PhD study chair
Centre de Recherche en Nutrition Humaine Rhone-Alpe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in people with Type2 Diabetes, run by Mondelēz International, Inc. 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 17 inclusion and 31 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 27 May 2020. 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. 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?
Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS (time frame: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record). 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 NCT03289494, 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 27 May 2020.