Trial Outcomes & Findings for Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) (NCT NCT00455325)

Results Overview

Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

assessed every 8 - 10 weeks at the end of each treatment period

Results posted on

2022-05-10

Participant Flow

Eligibility included adults with at least 3 criteria of metabolic syndrome but who did not have diabetes. Subjects were studied in the setting of a single academic health center. First participant was screened on 08 September 2004. The last study visit occurred on 08 June 2010.

144 participants were screened

Participant milestones

Participant milestones
Measure	Placebo Comparator: First Intervention (3 Weeks) Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	Second Intervention (3 Weeks) 80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	Third Intervention (3 Weeks) 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Fourth Intervention (3 Weeks) 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Cohort 1: Placebo STARTED	35	0	0	0
Cohort 1: Placebo COMPLETED	27	0	0	0
Cohort 1: Placebo NOT COMPLETED	8	0	0	0
Cohort 2: 80 mg Chloroquine Weekly STARTED	0	27	0	0
Cohort 2: 80 mg Chloroquine Weekly COMPLETED	0	26	0	0
Cohort 2: 80 mg Chloroquine Weekly NOT COMPLETED	0	1	0	0
Cohort 3: 80 mg Chloroquine Daily STARTED	0	0	26	0
Cohort 3: 80 mg Chloroquine Daily COMPLETED	0	0	25	0
Cohort 3: 80 mg Chloroquine Daily NOT COMPLETED	0	0	1	0
Cohort 4: 250mg Chloroquine Daily STARTED	0	0	0	25
Cohort 4: 250mg Chloroquine Daily COMPLETED	0	0	0	25
Cohort 4: 250mg Chloroquine Daily NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Comparator: First Intervention (3 Weeks) Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	Second Intervention (3 Weeks) 80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	Third Intervention (3 Weeks) 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Cohort 1: Placebo Started exclusionary drug	1	0	0
Cohort 1: Placebo Withdrawal by Subject	4	0	0
Cohort 1: Placebo Lost to Follow-up	1	0	0
Cohort 1: Placebo New diagnosis of Type 2 Diabetes	1	0	0
Cohort 1: Placebo DIFFICULTY WITH IV ACCESS	1	0	0
Cohort 2: 80 mg Chloroquine Weekly Adverse Event	0	1	0
Cohort 3: 80 mg Chloroquine Daily Started exclusionary drug	0	0	1

Baseline Characteristics

Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Subject n=35 Participants All Randomized Subjects
Age, Continuous	47 years STANDARD_DEVIATION 8.5 • n=93 Participants
Sex: Female, Male Female	26 Participants n=93 Participants
Sex: Female, Male Male	9 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race/Ethnicity, Customized White	32 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=93 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: assessed every 8 - 10 weeks at the end of each treatment period

Population: Full Analysis Set included all randomized participants who completed all procedures in the study arm

Hepatic insulin sensitivity was measured by comparing glucose production at baseline of zero insulin infusion rate with glucose production at 56 pmol/m2/min. Hepatic insulin sensitivity was expressed as the percent suppression, such that greater percent suppression indicated greater hepatic insulin sensitivity. There are no reference values, since the patients served as their own controls.

Outcome measures

Outcome measures
Measure	Placebo Comparator: First Intervention (3 Weeks) n=27 Participants Chloroquine placebo one tablet daily for 3 weeks Placebo Comparator Limb 1: 1 chloroquine placebo tablet for 3 weeks followed by 5-7 week rest period	Second Intervention (3 Weeks) n=26 Participants 80mg Chloroquine weekly for 3 weeks followed by 5-7 week rest period	Third Intervention (3 Weeks) n=25 Participants 80mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.	Fourth Intervention (3 Weeks) n=25 Participants 250mg chloroquine tablet daily: for 3 weeks, followed by 5-7 week rest period.
Insulin Sensitivity	.56 % suppression inf rate 56 pmol/m2/min Standard Deviation 0.04	0.55 % suppression inf rate 56 pmol/m2/min Standard Deviation 0.05	0.66 % suppression inf rate 56 pmol/m2/min Standard Deviation 0.06	0.70 % suppression inf rate 56 pmol/m2/min Standard Deviation 0.04

SECONDARY outcome

Timeframe: Assessed every 8-10 weeks at the end of each treatment period

Population: Full Analysis Set included all randomized participants who completed all procedures in the study arm

Two techniques were employed: auscultation of seated subjects at rest was performed by a trained observer who recorded the first and fifth phases of the Korotkoff sounds; and, a portable oscillometric device (SpaceLabs Medical) recorded results every 20 min during the day and every hour during the night. Data were analyzed as mean values over 24 hours.