NCT00574834

Brief Summary

The study will be focused on determining the integrated in-vivo mechanisms responsible for Ramipril's effects on delaying type 2 diabetes and restoring normal (blood sugar levels) glycemia in patients with impaired glucose tolerance. Hypothesis - Ramipril effects will delay the onset of type 2 diabetes and restore normal glycemia in patients with impaired glucose tolerance.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2007

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 15, 2016

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

7.4 years

First QC Date

December 13, 2007

Results QC Date

December 10, 2015

Last Update Submit

September 10, 2019

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Changes in Insulin Sensitivity

    Measures of change in endogenous glucose production from baseline to final 30 minutes of clamp studies after 6 months of treatment.

    6 months

Study Arms (3)

Ramipril

ACTIVE COMPARATOR

Patients randomized to 6 months treatment of Ramipril.

Drug: Ramipril

HCTZ

ACTIVE COMPARATOR

PAtients randomized to 6 months treatment of HCTZ.

Drug: HCTZ-hydrochlorothiazide

Ramipril+HCTZ

ACTIVE COMPARATOR

Patients randomized to 6 months treatment of Ramipril+HCTZ.

Drug: Ramipril+HCTZ

Interventions

RamiprilDRUG

Ramipril 20 mg once daily for 6 months

Also known as: Altace
Ramipril
HCTZ-hydrochlorothiazideDRUG

HCTZ 25 mg once daily for 6 months

Also known as: Brand Names: HydroDIURIL, Microzide
HCTZ
Ramipril+HCTZDRUG

Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months

Also known as: Altace and HydroDIURIL, Microzide
Ramipril+HCTZ

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (24 male / 24 female) with impaired glucose tolerance.
  • Impaired blood glucose values as outlined by the American Diabetes Association guideline. Fasting plasma glucose between 100 and 126 mg/dl or 2 hour post prandial glucose between 140 and 200 mg/dl
  • BMI \> 25 kgM2
  • Age: 20-65 years
  • Treated or Untreated hypertension defined as measurement of seated BP at screening visit of systolic BP 120 to 150 and/ or diastolic BP 80 to 100.

You may not qualify if:

  • Patients receiving agents that can increase or lower blood glucose, i.e., metformin, thiazolidinediones, sulfonylureas, glitinides, acarbose, GLP-1 receptor agonists
  • Untreated or treated while seated Systolic Blood pressure \>150and/or Diastolic Blood pressure \>100
  • Taking hypertensive medications of HCTZ or ACE/ARB
  • Allergy to HCTZ, heparin, nitroglycerin or lidocaine
  • History of allergy or unacceptable side effects from ACE inhibitors
  • Pregnancy or intent to become pregnant during the study
  • Smoking
  • Subject unable to give voluntary informed consent
  • Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) from history or ECG in subjects \> 40 years old
  • Pneumonia
  • Hepatic Failure/Jaundice
  • Renal Failure
  • Acute Cerebrovascular/ Neurological deficit
  • Fever greater than 38.0 C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

RamiprilHydrochlorothiazide

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazides

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed. No conclusions drawn.

Results Point of Contact

Title
Stephen N. Davis, MBBS- Principal Investigator
Organization
University of Maryland Baltimore
sdavis@medicine.umaryland.edu
410-328-2488

Study Officials

  • Stephen N. Davis, MD, FRCP

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 12, 2019

Results First Posted

January 15, 2016

Record last verified: 2019-09

Locations

US(1)