Lifestyle Changes in Patients With Type 2 Diabetes Mellit... | NCT01461330

Studies
Lifestyle Changes in Patients With Type 2 Diabetes Mellitus and Hypertension

NCT01461330

Sponsor

Hospital de Clinicas de Porto Alegre

Status

Terminated

Last Update Posted

Jan 26, 2017Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Blood Pressure

Interventions

DASH diet plus exercise
ADA diet

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

Jan 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011Actual

Primary Completion Date

Oct 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Aug 3, 2011

First Submission Date that Met QC Criteria

Oct 27, 2011

First Posted Date

Oct 28, 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

Jan 25, 2017

Last Update Posted Date

Jan 26, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mirela Jobim de Azevedo, Dr., MD, Associated Professor of Medicine, Hospital de Clinicas de Porto AlegrePrincipal Investigator

Lead Sponsor

Hospital de Clinicas de Porto AlegreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Data obtained in hypertensive patients without diabetes suggest that increased association of non-pharmacological treatment in patients with diabetes and hypertension may be associated with an improvement in blood pressure control. Despite the beneficial results found, is not yet known the magnitude of the effect of a DASH diet associated with the stimulus of physical activity on BP in patients with type 2 diabetes. The beneficial effects on blood pressure of an additional non-pharmacological intervention to drug therapy may have an even greater impact in patients with treatment-resistant hypertension The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension resistant to treatment.

Detailed Description

The aim of this study is to evaluate the effect of changes in lifestyle on blood pressure in patients with type 2 diabetes and hypertension. Secondary objectives are: Assess whether the prescription of a DASH-type diet and encouragement for physical activity through use of pedometers, can improve blood pressure control in patients with type 2 diabetes and hypertension resistant to treatment.

Forty type 2 diabetic with resistant hypertension outpatients were included in a randomized clinical trial: treatment 1- DASH diet + encouragement for physical activity through use of pedometer; treatment 2- ADA diet + usual exercises. The duration of each treatment are four weeks. The patients included should have performed Ambulatory Blood Pressure Monitoring (ABPM) to exclude white-coat effect, ie when there are abnormal in the measurement of office blood pressure (equal to or above 140/90 mm Hg) and normal blood pressure by ABPM during the awake period (equal to or below 135/85 mm Hg). Twenty-four hour records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 weeks. Serum fatty acids were measured in total lipids by gas chromatography.

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DASH diet	Experimental	DASH DIET + EXERCISE	Other: DASH diet plus exercise
ADA DIET	Active Comparator	DIET ACCORDING AMERICAN DIABETES ASSOCIATION DIETARY RECOMMENDATIONS FOR DIABETES	Other: ADA diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DASH diet plus exercise	Other	DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from Baseline in Blood Pressure at 4 weeks	Ambulatory Blood Pressure Monitoring (ABPM) at baseline and after 4 weeks	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in glucose control at 4 weeks	A1 C test at baseline and after 4 weeks	4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patients

Inclusion Criteria:

type 2 diabetes
Blood pressure ≥140/90 mm Hg
ABMP ≥ 135/85 mm Hg

Exclusion Criteria:

digestive disease with malabsorption
diabetic neuropathy with gastroparesis
BMI ≥ 40 kg/m²

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tatiana P de Paula, RD	Hospital de Clínicas de Porto Alegre	Study Chair
Luciana Verzoça, MD	Hospital de Clínicas de Porto Alegre	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D009043	Motor Activity

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000073601	Dietary Approaches To Stop Hypertension
D015444	Exercise

Ancestor Terms

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

intervention: DASH diet plus exercise DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat Exercises: the recommended physical activity will consist of using a pedometer during the experimental period.

active comparator = ADA diet = Adoption of ADA diet.