Sustained Effects of a Non-glucidic Nutrient Preload on Glucose Tolerance in Type 2 Diabetes
1 other identifier
interventional
7
1 country
1
Brief Summary
The investigators aimed at evaluating the effects of a small non-glucidic nutrient preload on plasma glucose, insulin, C-peptide, glucagon-like peptide-1, and glucose-dependent insulinotropic polypeptide concentrations after the meal consumption and for 300 min after a 75 g glucose ingestion in diet-controlled type 2 diabetic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes
Started Jun 2015
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJune 23, 2015
June 1, 2015
3 months
June 17, 2015
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma glucose concentration
330 minutes
Secondary Outcomes (4)
Plasma Insulin concentration
330 minutes
Plasma C-peptide concentration
330 minutes
Plasma glucagon-like peptide-1 concentration
330 minutes
Plasma glucose-dependent insulinotropic polypeptide concentration
330 minutes
Study Arms (2)
Water preload
NO INTERVENTIONDuring the "Water preload" study, each subject consume 500 ml of water 30 minutes before a 75 g glucose ingestion
Nutrient preload
EXPERIMENTALDuring the "Nutrient preload" study, each subject consume a small mixed meal 30 minutes before a 75 g glucose ingestion. The meal is composed by 50 g of parmesan cheese, one small size boiled egg and 300 ml of water (250 kcal, 23 g protein, 17 g fat and 2 g of carbohydrate).
Interventions
Ingestion of a small mixed protein and lipid meal 30 minutes before glucose
Eligibility Criteria
You may qualify if:
- Diet-controlled type 2 diabetic patients
- Subjects ≥ 18 and ≤65 years of age
- Lean, Overweight or Obese (BMI: 18 to 35 kg/m2)
- Normal liver and kidney function
- Normal thyroid function
- Read and understood the informed consent form and signed it voluntarily
You may not qualify if:
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
- Type 1 or insulin treated diabetes.
- Pregnancy or lactation
- Illicit drug abuse or alcoholism
- Subjects taking anoretic drugs
- Subjects on steroid treatment
- Subjects after bariatric surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56127, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrea Natali, Prof
Azienda Ospedaliero, Universitaria Pisana
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 23, 2015
Study Start
June 1, 2015
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
June 23, 2015
Record last verified: 2015-06