NCT00282178

Brief Summary

The purpose of this study is to investigate the effect of a 12-week candesartan treatment compared with hydrochlorothiazide on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Apr 2005

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 16, 2008

Status Verified

June 1, 2008

Enrollment Period

11 months

First QC Date

January 24, 2006

Last Update Submit

October 15, 2008

Conditions

HypertensionObesity

Keywords

MetabolicHypertensionAbdominal obesityInsulin sensitivityHyperinsulinemic euglycemic clamp

Outcome Measures

Primary Outcomes (1)

  • Compare the effect of candesartan and hydorclorothiszide treatment on insulin sensitivity assessed with hyperinsulinemic euglycemic clamp

    12 weeks

Secondary Outcomes (10)

  • Compare the effect of candesartan treatment with placebo on insulin sensitivity and compared with hydrochlorothiazide and placebo on:

    12 weeks

  • beta cell function

    12 weeks

  • vascular/endothelial function;

    12 weeks

  • lipolysis regulation

    12 weeks

  • autonomic nerve activity;

    12 weeks

  • +5 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

Candesartan 16-32 mg once daily

Drug: Candesartan

2

ACTIVE COMPARATOR

Hydrochlorothiazide 25-50 mg once daily

Drug: Hydrochlorothiazide

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

HydrochlorothiazideDRUG

25-50 mg once daily

2
PlaceboDRUG

Once daily

3
CandesartanDRUG

16-32 mg once daily 12 weeks

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female 18-70 years old
  • Diagnosed hypertension and abdominal obesity (waist circumference greater than or equal to 102 cm (M) or 88 cm (F)

You may not qualify if:

  • Uncontrolled hypertension
  • Treatment with more than two concomitant antihypertensive medications
  • Diabetes Mellitus
  • Other endocrine disorder
  • Severe liver disease
  • Severely reduced renal function
  • Malignant disease
  • Alcohol or drug abuse
  • Severe psychiatric illness
  • History of stroke, myocardial infarction, unstable angina pectoris, participation in another clinical trial less than two months prior to screening visit
  • treatment with anti-obesity drugs
  • anti-inflammatory drugs or immunosuppressive drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umeå University Hospital

Umeå, SE-90185, Sweden

Location

MeSH Terms

Conditions

HypertensionObesityObesity, AbdominalInsulin Resistance

Interventions

Hydrochlorothiazidecandesartan

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

ChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jan Eriksson, MD, PhD

    Dept of Medicine, Umeå University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2006

First Posted

January 25, 2006

Study Start

April 1, 2005

Primary Completion

March 1, 2006

Study Completion

April 1, 2006

Last Updated

October 16, 2008

Record last verified: 2008-06

Locations

SE(1)