- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01410292
Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Design study:
Single-blind crossover randomized clinical trial
Hypothesis:
A meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.
Test meals:
Four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):
Test Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)
Outcomes:
Glycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.
Logistic:
Patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.
All participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien
- Rekruttering
- Hospital de Clínicas de Porto Alegre
-
Kontakt:
- Flávia M Silva
- Telefonnummer: 93771824
- E-mail: flavia.moraes.silva@hotmail.com
-
Underforsker:
- Thais Steemburgo
-
Underforsker:
- Caroline Kramer
-
Underforsker:
- Giovana Menegotto
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- type 2 diabetes,
- HbA1c < 9%,
- BMI < 35kg/m²,
- Metformin and/or diet as treatment for diabetes
Exclusion Criteria:
- Use of insulin as diabetes treatment
- digestive disease with malabsorption
- diabetes neuropathy with gastroparesis
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: meal D
low fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
Eksperimentel: meal C
low Fiber and High GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
Eksperimentel: meal B
high Fiber and low GI
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
Eksperimentel: meal A
high fiber and high GI meal
|
meals with different fiber content and glycemic index
four different meal regarding GI and fiber content
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
glycemic control
Tidsramme: fasting and post-prandial (differents times during 180 minutes)
|
glucose and insulin
|
fasting and post-prandial (differents times during 180 minutes)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
measures of satiety and appetite
Tidsramme: fasting and post-prandial (different times for 180 min)
|
ghrelin and subjective analogue scale of appetite
|
fasting and post-prandial (different times for 180 min)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Flávia M Silva, Hospital de Clínicas de Porto Alegre
- Studiestol: Thais Steemburgo, Hospital de Clínicas de Porto Alegre
- Studiestol: Caroline Kramer, Hospital de Clínicas de Porto Alegre
- Studiestol: Giovana Menegotto, Hospital de Clínicas de Porto Alegre
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GPPG 10-0472
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-
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