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Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity (REVIVE)

Primary Purpose

Obesity, Metabolic Syndrome X

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Metformin

Orlistat

Topiramate

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Metabolic Syndrome X, Hypertension, Dyslipidemia, Impaired glucose tolerance

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 40 to 75 years
Male or postmenopausal female
BMI ≥ 30 kg/m2
One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

Congestive heart failure
Renal impairment
History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
Type I diabetes mellitus
Weight loss > 10% in the past 6 months
Recurrent nephrolithiasis
Current treatment for seizure disorder
Hepatic cirrhosis
Current use of study medications
Current use of oral estrogen
History of smoking cessation in the past three months
Current cholestasis or malabsorption syndrome
Planned use of any herbal or over-the-counter supplements for weight loss
History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
Participation in another clinical drug study within four weeks prior to this investigation.
Participation in any other weight loss or rigorous exercise program.
Any disease or condition that in the opinion of the investigator may interfere with completion of the study

Sites / Locations

University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Metformin

Metformin + Orlistat

Metformin + Topiramate

Topiramate

Metformin + Topiramate + Orlistat

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Weight (% Change From Baseline)

Weight obtained in the fasting state on a gowned subject.

Secondary Outcome Measures

Office Systolic Blood Pressure (mmHg Change From Baseline)

Automated sphygmomanometry while sitting

Waist (cm Change After 6 Months From Baseline)

Body fat distribution measured using anthropometry (waist, neck and hip circumferences)

Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline)

Change in carotid-femoral pulse wave velocity (Sphygmocor).

Full Information

NCT ID

NCT01351753

First Posted

May 4, 2011

Last Updated

May 13, 2021

Sponsor

University of Iowa

1. Study Identification

Unique Protocol Identification Number

NCT01351753

Brief Title

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

Acronym

REVIVE

Official Title

Does Reversal of Visceral Obesity by Drug Therapy Improve Vascular Function?

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Lack of funding

Study Start Date

March 2011 (Actual)

Primary Completion Date

January 9, 2014 (Actual)

Study Completion Date

January 9, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Iowa

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Obesity is common (>30% of US adults), contributes to substantial morbidity and mortality, but is difficult to treat. Partly this is due to the transient, arduous and modest nature of lifestyle interventions. Partly it is due to the limited efficacy and safety problems of existing pharmacotherapy. Only one drug, orlistat, is approved for long-term use in obesity; but its effects on weight are relatively small. There are drugs that have been approved for other diseases but which also reduce weight. One promising approach to treating obesity is combination therapy with orlistat and one or more of these other agents. The investigators propose an innovative approach to developing new therapies for obesity coupling the use of combination therapy with rigorous assessment of cardiovascular safety. Vascular function is a quantitative surrogate clinical endpoint that has been strongly and independently linked to future cardiovascular events. Our hypothesis is that combination pharmacotherapy will reduce weight and improve vascular function in obese human subjects. The co-primary endpoints will be weight and vascular function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Metabolic Syndrome X

Keywords

Obesity, Metabolic Syndrome X, Hypertension, Dyslipidemia, Impaired glucose tolerance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

136 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Active Comparator

Arm Title

Metformin + Orlistat

Arm Type

Experimental

Arm Title

Metformin + Topiramate

Arm Type

Experimental

Arm Title

Topiramate

Arm Type

Experimental

Arm Title

Metformin + Topiramate + Orlistat

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Type

Drug

Intervention Name(s)

Orlistat

Intervention Type

Drug

Intervention Name(s)

Topiramate

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo pills and capsules for metformin, orlistat and topiramate

Primary Outcome Measure Information:

Title

Weight (% Change From Baseline)

Description

Weight obtained in the fasting state on a gowned subject.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Office Systolic Blood Pressure (mmHg Change From Baseline)

Description

Automated sphygmomanometry while sitting

Time Frame

6 months

Title

Waist (cm Change After 6 Months From Baseline)

Description

Body fat distribution measured using anthropometry (waist, neck and hip circumferences)

Time Frame

6 months

Title

Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline)

Description

Change in carotid-femoral pulse wave velocity (Sphygmocor).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 40 to 75 years Male or postmenopausal female BMI ≥ 30 kg/m2 One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome) Exclusion Criteria: Congestive heart failure Renal impairment History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion) Type I diabetes mellitus Weight loss > 10% in the past 6 months Recurrent nephrolithiasis Current treatment for seizure disorder Hepatic cirrhosis Current use of study medications Current use of oral estrogen History of smoking cessation in the past three months Current cholestasis or malabsorption syndrome Planned use of any herbal or over-the-counter supplements for weight loss History of allergic reactions to metformin, topiramate, orlistat or any of ingredients Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours Participation in another clinical drug study within four weeks prior to this investigation. Participation in any other weight loss or rigorous exercise program. Any disease or condition that in the opinion of the investigator may interfere with completion of the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary L Pierce, PhD

Organizational Affiliation

University of Iowa

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52241

Country

United States

12. IPD Sharing Statement

Links:

URL

http://goo.gl/IHNtm

Description

Recruitment website

Learn more about this trial

Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity

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