Trial Outcomes & Findings for Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects (NCT NCT03991299)

NCT ID: NCT03991299

Last Updated: 2023-02-28

Results Overview

Body weight will be measured at baseline and 6 months after Botox injections.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline - 6 months
• Results posted on: 2023-02-28

Participant Flow

4 participants enrolled. 1 participants withdrew.

Participant milestones

Measure	Botox Arm Botox will be injected into duodenums of subjects via endoscopy. Botox 200 UNT Injection: Botox will be injected into duodenums of subjects by endoscopy.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Botox Arm Botox will be injected into duodenums of subjects via endoscopy. Botox 200 UNT Injection: Botox will be injected into duodenums of subjects by endoscopy.
Overall Study Study closed, sponsor decision	3
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Investigating Effects of BOTOX on Weight Loss and Glucose Tolerance in Obese, Type 2 Diabetic Subjects

Baseline characteristics by cohort

Measure	BOTOX Arm n=4 Participants Botox will be injected into duodenums of subjects via endoscopy. Botox 200 UNT Injection: Botox will be injected into duodenums of subjects by endoscopy.
Age, Continuous	43.7 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline - 6 months

Population: Data analysis could not be completed as zero participants remained enrolled in the study for 30 days or more

Body weight will be measured at baseline and 6 months after Botox injections.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline - 3 months

Population: Data analysis could not be completed as zero participants remained enrolled in the study for 30 days or more

Body weight will be measured at baseline and 3 months after Botox injections.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Baseline - 1 month

Population: Data analysis could not be completed as zero participants remained enrolled in the study for 30 days or more

Body weight will be measured at baseline and 1 month after Botox injections.

Outcome measures

Outcome data not reported

Adverse Events

Botox Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Botox Arm n=4 participants at risk Botox will be injected into duodenums of subjects via endoscopy. Botox 200 UNT Injection: Botox will be injected into duodenums of subjects by endoscopy.
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Number of events 1 • Baseline to four weeks
Musculoskeletal and connective tissue disorders Joint pain	25.0% 1/4 • Number of events 1 • Baseline to four weeks

Additional Information

Dr Cyndya Shibao

Vanderbilt University Medical Center

Phone: 6159364584

Email: cyndya.shibao@vumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place