Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04863755
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2021-04-08
Brief Title:
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
Change of Lifestyle in Elderly Patients With Type 2 Diabetes and Systemic Arterial Hypertension Effects of DASH Diet and Physical Activity on Blood Pressure and Insulin Sensitivity
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Evaluate the effect of lifestyle modification through the adoption of a DASH diet with and without physical activity guidance on blood pressure and insulin sensitivity in elderly patients with type 2 diabetes and hypertension
Detailed Description:
Data regarding the effects of physical activity and DASH-type diet on blood pressure control in patients with type 2 diabetes and hypertension are scarce in the literature whether evaluating these isolated interventions or together In addition most studies do not measure BP using ABPM which has a special importance in the assessment of pressure homeostasis in DM or are short-term studies Were only two studies have been identified in the literature that evaluated the effect of the DASH diet on patients with type 2 DM however in both trials being elderly was not an inclusion criterion The first was an Iranian study that demonstrated in 31 non-hypertensive patients a significant reduction in BP after 8 weeks of following a DASH diet In the second ECR we demonstrated that in 20 hypertensive type 2 DM patients all using antihypertensive drugs and with uncontrolled BP a DASH-type diet for 4 weeks associated with physical activity reduced the systolic BP assessed by ABPM by 125 mmHg However the adopted design did not allow to separate the effect of diet from the effect of physical activity On the other hand the effect of a single session of walking followed by a 24-hour ABPM assessment showed a reduction in BP in hypertensive elderly and non-hypertensive patients also without DM So far it is not defined in patients with type 2 DM and hypertension especially the elderly whether the DASH diet alone is as beneficial for BP as its association with physical activity particularly considering the difficulties of performing exercises in this group of patients This is valuable information as it would reinforce the role of diet therapy intervention even if in isolation in this age group Furthermore the role of the DASH diet with or without physical activity remains unknown on insulin sensitivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None