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Body Weight Response With Disulfiram in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05162001
Recruitment Status : Enrolling by invitation
First Posted : December 17, 2021
Last Update Posted : December 17, 2021
Sponsor:
Collaborator:
Laboratorios Doctor Macías
Information provided by (Responsible Party):
Alejandro E. Macias, Universidad de Guanajuato

Brief Summary:
Overweight and obesity due to food that exceeds the requirements is an increasingly common global problem. Lifestyle intervention and anorectic drugs result in minimal weight loss, which tends to be easily regained. In addition, drugs tend to have too many side effects and have had to be withdrawn from management schemes and even from the market. Disulfiram (Antabuse®️) is approved by the Food and Drug Administration against chronic alcohol addiction. In a mouse study, disulfiram prevented body weight gain and negated the adverse impact of an obesogenic diet on insulin; used properly it is a safe drug. Carrying out a testing-concept study with disulfiram will allow the establishment of guidelines on clinical studies focused on its use as an adjunct in the reduction and control of body weight.

Condition or disease Intervention/treatment Phase
Obesity; Drug Drug: Disulfiram 250 mg Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Body Weight Response With Disulfiram in Humans. Concept Testing Study
Actual Study Start Date : November 21, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Disulfiram

Arm Intervention/treatment
Experimental: Disulfiram
A group of adults with a body mass index bigger than 22, treated with disulfiram
Drug: Disulfiram 250 mg
Disulfiram used qd during nine weeks to observe effects on body weight
Other Name: Antabuse




Primary Outcome Measures :
  1. Body weight change [ Time Frame: nine weeks ]
    Daily weight in the morning fasting for 8 hours or more, with light underwear, at the same time of day and on the same clinical scale (Tanita 585f, Tokyo, Japan), which have a precision of +/- 100 g.


Secondary Outcome Measures :
  1. Changes in hematic cytology [ Time Frame: nine weeks ]
    Laboratory test within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Hematic cytology. Units of measurement: cells by mm^3

  2. Changes in Erythrocyte sedimentation rate. [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Erythrocyte sedimentation rate. Unit of measurement: mm/hour

  3. Changes in C-reactive protein. [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: C-reactive protein. Unit of measurement: mg/L

  4. Changes in glucose [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Glucose. Unit of measurement: mg/dL

  5. Changes in creatinine. [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Creatinine. Unit of measurement: mg/dL

  6. Changes in total bilirubins. [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: total bilirubins. Unit of measurement: mg/dL.

  7. Changes in Alanine- Aminotransferase. [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Alanine-Aminotransferase Unit of measurement: IU/L

  8. Changes in Aspartate-aminotransferase [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Aspartate-aminotransferase. Unit of measurement: IU/L

  9. Changes in cholesterol [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Cholesterol. Unit of measurement: mg/dL

  10. Changes in triglycerides [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: Triglycerides. Unit of measurement: mg/dL

  11. Changes in HDL cholesterol [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: HDL cholesterol. Unit of measurement: mg/dL

  12. Changes in LDL cholesterol [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: LDL cholesterol. Unit of measurement: mg/dL

  13. Changes in General urine test [ Time Frame: nine weeks ]
    Laboratory tests within 72 hours before the start of the study, as well as 7 days and the last day of treatment and four weeks after the end of treatment. Blood tests with a minimum fasting of 8 h: General urine test. Unit of measurement: positive/negative



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults
  • 18 to 65 years old
  • height >160 cm
  • fast weight >65 Kg
  • Body Mass Index (BMI) >22.

Exclusion Criteria:

  • Diabetes
  • vascular diseases
  • liver diseases
  • renal failure
  • cancer
  • chronic obstructive pulmonary disease (COPD)
  • alcohol, drugs or tobacco addiction
  • convulsive diseases
  • hypothyroidism
  • tuberculosis or chronic debilitating diseases
  • use of statins or other lipid lowering drugs
  • anticoagulants drugs
  • herbal remedies.
  • For women 18 to 50 years old, pregnancy should ruled out with a proper test before recruiting and anti conceptive measures must be started in case of active sexual life during all the time of the study and 2 additional weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05162001


Locations
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Mexico
University of Guanajuato
Leon, Guanajuato, Mexico, 37000
Sponsors and Collaborators
Universidad de Guanajuato
Laboratorios Doctor Macías
Investigators
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Principal Investigator: Alejandro E Macias, MD Universidad de Guanajuato
Publications of Results:

Other Publications:
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Responsible Party: Alejandro E. Macias, Tenure professor, Universidad de Guanajuato
ClinicalTrials.gov Identifier: NCT05162001    
Other Study ID Numbers: Disulfiram-01-2021
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: It will be shared with other researchers as solicited, as long as the individual participants agree.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alejandro E. Macias, Universidad de Guanajuato:
Obesity
Overweight
Obesity drug
Additional relevant MeSH terms:
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Obesity
Body Weight
Overnutrition
Nutrition Disorders
Overweight
Disulfiram
Alcohol Deterrents
Acetaldehyde Dehydrogenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action