Trial Outcomes & Findings for GAstric Bypass to Treat obEse Patients With steAdy hYpertension (NCT NCT01784848)

Results Overview

Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (\<140x90 mmHg), in 12 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

12 months

Results posted on

2022-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Laparoscopic Roux-en-Y Gastric Bypass Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.	Clinical Treatment Optimized clinical treatment including medical management of hypertension. Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.
Overall Study STARTED	50	50
Overall Study COMPLETED	49	47
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GAstric Bypass to Treat obEse Patients With steAdy hYpertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laparoscopic Roux-en-Y Gastric Bypass n=50 Participants Laparoscopic Roux-en-Y gastric bypass performed as a treatment for obesity. Laparoscopic Roux-en-Y gastric bypass (LRYGB): Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.	Clinical Treatment n=50 Participants Optimized clinical treatment including medical management of hypertension. Clinical treatment: Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.	Total n=100 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 9.2 • n=5 Participants	44.6 years STANDARD_DEVIATION 9.2 • n=7 Participants	43.8 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Anti-hypertensive medications	3 Anti-hypertensive medications n=5 Participants	3 Anti-hypertensive medications n=7 Participants	3 Anti-hypertensive medications n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Evaluate the efficacy of Roux-en-Y Gastric Bypass on the reduction of the number of antihypertensive drugs, maintaining a controlled blood pressure (\<140x90 mmHg), in 12 months.