Body Weight Response With Disulfiram in Humans

NCT05162001 | Unknown Early Phase 1 DMC

• 1 other identifier: Disulfiram-01-2021
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 In addition, drugs tend to have too many side effects and have had to be withdrawn from management schemes and even from the market.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.

Conditions

Obesity; Drug

Keywords

Obesity; Overweight; Obesity drug

Outcome Measures

Primary Outcomes (1)

• Body weight change

  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.

  nine weeks

Secondary Outcomes (13)

• Changes in hematic cytology

  nine weeks

• Changes in Erythrocyte sedimentation rate.

  nine weeks

• Changes in C-reactive protein.

  nine weeks

• Changes in glucose

  nine weeks

• Changes in creatinine.

  nine weeks

Study Arms (1)

Disulfiram

EXPERIMENTAL

A group of adults with a body mass index bigger than 22, treated with disulfiram

Drug: Disulfiram 250 mg

Interventions

Disulfiram 250 mg DRUG

Disulfiram used qd during nine weeks to observe effects on body weight

Also known as: Antabuse

Disulfiram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• Laboratorios Doctor Macías: collaborator

Study Sites (1)

University of Guanajuato

León, Guanajuato, 37000, Mexico

Location

Related Publications (6)

• Hall KD, Kahan S. Maintenance of Lost Weight and Long-Term Management of Obesity. Med Clin North Am. 2018 Jan;102(1):183-197. doi: 10.1016/j.mcna.2017.08.012.

  PMID: 29156185 BACKGROUND

• Chouchani ET, Kazak L, Spiegelman BM. New Advances in Adaptive Thermogenesis: UCP1 and Beyond. Cell Metab. 2019 Jan 8;29(1):27-37. doi: 10.1016/j.cmet.2018.11.002. Epub 2018 Nov 29.

  PMID: 30503034 RESULT

• Seale P, Conroe HM, Estall J, Kajimura S, Frontini A, Ishibashi J, Cohen P, Cinti S, Spiegelman BM. Prdm16 determines the thermogenic program of subcutaneous white adipose tissue in mice. J Clin Invest. 2011 Jan;121(1):96-105. doi: 10.1172/JCI44271. Epub 2010 Dec 1.

  PMID: 21123942 RESULT

• Teijeiro A, Garrido A, Ferre A, Perna C, Djouder N. Inhibition of the IL-17A axis in adipocytes suppresses diet-induced obesity and metabolic disorders in mice. Nat Metab. 2021 Apr;3(4):496-512. doi: 10.1038/s42255-021-00371-1. Epub 2021 Apr 15.

  PMID: 33859430 RESULT

• Bernier M, Mitchell SJ, Wahl D, Diaz A, Singh A, Seo W, Wang M, Ali A, Kaiser T, Price NL, Aon MA, Kim EY, Petr MA, Cai H, Warren A, Di Germanio C, Di Francesco A, Fishbein K, Guiterrez V, Harney D, Koay YC, Mach J, Enamorado IN, Pulpitel T, Wang Y, Zhang J, Zhang L, Spencer RG, Becker KG, Egan JM, Lakatta EG, O'Sullivan J, Larance M, LeCouteur DG, Cogger VC, Gao B, Fernandez-Hernando C, Cuervo AM, de Cabo R. Disulfiram Treatment Normalizes Body Weight in Obese Mice. Cell Metab. 2020 Aug 4;32(2):203-214.e4. doi: 10.1016/j.cmet.2020.04.019. Epub 2020 May 14.

  PMID: 32413333 RESULT

• Bernier M, Harney D, Koay YC, Diaz A, Singh A, Wahl D, Pulpitel T, Ali A, Guiterrez V, Mitchell SJ, Kim EY, Mach J, Price NL, Aon MA, LeCouteur DG, Cogger VC, Fernandez-Hernando C, O'Sullivan J, Larance M, Cuervo AM, de Cabo R. Elucidating the mechanisms by which disulfiram protects against obesity and metabolic syndrome. NPJ Aging Mech Dis. 2020 Jul 21;6:8. doi: 10.1038/s41514-020-0046-6. eCollection 2020.

  PMID: 32714562 RESULT

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Disulfiram

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ditiocarb; Thiocarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Disulfides; Sulfides; Sulfur Compounds

Study Officials

• Alejandro E Macias, MD

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure professor

Study Record Dates

• First Submitted: November 14, 2021
• First Posted: December 17, 2021
• Study Start: November 21, 2021
• Primary Completion: January 31, 2022
• Study Completion: April 30, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)