Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)
Condition: Metabolic Syndrome X; Overweight; Hypertension; Dyslipidemias; Prediabetic State
MeSH terms: Overweight; Metabolic Syndrome; Dyslipidemias; Prediabetic State; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Metabolic syndrome consists of a group of co-occuring conditions that increase an
      individual's risk of developing heart disease, stroke, and diabetes. The purpose of this
      study is to evaluate the short-term effectiveness of chloroquine, a protein-activation
      medication, at improving metabolic syndrome.
    

Detailed description: 
      Metabolic syndrome is one of the most common disorders in industrialized countries. It
      consists of abnormal serum lipids, glucose intolerance, elevated blood pressure, and central
      obesity in the setting of insulin resistance. The syndrome substantially increases the risk
      of developing diabetes and vascular disease, but there is no clear unifying approach to treat
      this disorder. In animals, activation of the protein ataxia telangiectasia mutated (ATM)
      using the antimalarial drug chloroquine improves features of metabolic syndrome and decreases
      atherosclerosis, a build-up of fatty plaque within arteries. The purpose of this study is to
      evaluate the effectiveness of short-term treatment with low doses of chloroquine as a way of
      managing metabolic syndrome.

      Participants in this study will initially receive placebo for 3 weeks, followed by increasing
      doses of chloroquine in three, 3-week intervals. Following each 3-week treatment,
      participants will be admitted to the research center for one day. There will be a period of
      no active treatment for 5 to 7 weeks following each admission to the research center to allow
      recovery from the blood drawing of the clamp procedure before the start of the next treatment
      interval.
    

Intervention name(s): Placebo Comparator: First Intervention (3 weeks); Active Comparator: Second Intervention (3 weeks); Active Comparator: Third Intervention (3 weeks); Active Comparator: Fourth Intervention (3 weeks)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once daily placebo tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Once daily 80mg chloroquine or placebo tablet 3 Weeks followed by euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Once daily 80mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells; Once daily 250mg tablet for 3 weeks followed by: euglycemic clamp procedure; 24 hour Ambulatory Blood Pressure; Oral Glucose tolerance Test; serum collection; 24 hour urine collection; collection of peripheral blood mononuclear cells
Other intervention name(s): Placebo once daily; 80 mg chloroquine or placebo tablet once daily; 80 mg chloroquine tablet once daily; 250 mg chloroquine tablet once daily
Intervention MeSH terms: Chloroquine; Chloroquine diphosphate
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insulin Resistance; Atherosclerosis; Metabolic Syndrome