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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type2 Diabetes
- Sponsor
- Mondelēz International, Inc.
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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).
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%
- •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)
Exclusion Criteria
- •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:
- •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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Glycemic profile parameters: total AUC(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MODDs(minimum 3 days to a maximum of 6 days of CGMS record)
- Dietary intake evaluation(After 1 week intervention diet)
- Charaterisation of acceptability to H-SDS diet in free living conditions(After 1 week intervention diet)
- Glycemic profile parameters: maximum glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: mean glycemic value(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: kinetics(minimum 3 days to a maximum of 6 days of CGMS record)
- Compliance parameters: mean SDS ingestion(maximum of 6 days of LogBook record)
- Dietary record evaluation(After 1 week intervention diet)
- Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MAGE(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: MIME(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Time in Range(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: CONGA(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: hyperglycemia durations(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: hypoglycemia durations(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: incremental AUC(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: Minimum glycaemia(minimum 3 days to a maximum of 6 days of CGMS record)
- Glycemic profile parameters: ADRR(minimum 3 days to a maximum of 6 days of CGMS record)