Glycemic and Satiety Response to Fiber and Glycemic Index... | NCT01410292

Studies
Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes

NCT01410292

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Unknown status

Last Update Posted

Aug 5, 2011Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes Mellitus

Interventions

GI and fiber meals
meals

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Sep 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Aug 3, 2011

First Submission Date that Met QC Criteria

Aug 4, 2011

First Posted Date

Aug 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2011

Last Update Posted Date

Aug 5, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hospital de Clinicas de Porto AlegreOTHER

Collaborators

Name	Class
Federal University of Rio Grande do Sul	OTHER
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
meal D	Experimental	low fiber and low GI	Other: GI and fiber meals Other: meals
meal C	Experimental	low Fiber and High GI	Other: GI and fiber meals Other: meals
meal B	Experimental	high Fiber and low GI	Other: GI and fiber meals Other: meals
meal A	Experimental	high fiber and high GI meal	Other: GI and fiber meals Other: meals

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GI and fiber meals	Other	meals with different fiber content and glycemic index	meal A meal B meal C meal D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
glycemic control	glucose and insulin	fasting and post-prandial (differents times during 180 minutes)

Secondary Outcomes

Measure	Description	Time Frame
measures of satiety and appetite	ghrelin and subjective analogue scale of appetite	fasting and post-prandial (different times for 180 min)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Flávia M Silva	Contact	93771824		flavia.moraes.silva@hotmail.com

Overall Officials

Name	Affiliation	Role
Flávia M Silva	Hospital de Clínicas de Porto Alegre	Study Chair
Thais Steemburgo	Hospital de Clínicas de Porto Alegre	Study Chair
Caroline Kramer

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clínicas de Porto Alegre	Recruiting	Porto Alegre	Rio Grande do Sul		Brazil

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25833777	Derived	Silva FM, Kramer CK, Crispim D, Azevedo MJ. A high-glycemic index, low-fiber breakfast affects the postprandial plasma glucose, insulin, and ghrelin responses of patients with type 2 diabetes in a randomized clinical trial. J Nutr. 2015 Apr;145(4):736-41. doi: 10.3945/jn.114.195339. Epub 2015 Feb 11.

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages