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

NCT03991299 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 181978
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will recruit obese subjects with pre-diabetes or type 2 diabetes for the proposed clinical study for 5 visits. After informed written consent is obtained, subjects will be admitted to the Clinical Research Center, and will undergo upper endoscopic injection of Botox into the duodenal wall. The investigators anticipate that injections of Botox into the duodenal wall will result in significant weight loss and improvements in glucose tolerance and duodenal nutrient sensitivity. Subjects will be studied over a period of 6 months. Subjects will be asked to complete 5 study visits: On the first visit, each subject will undergo an oral glucose tolerance test. At visit 2, subjects will undergo an esophagogastroduodenoscopy procedure for the delivery of Botox to the duodenal wall. Visits 3-5 will be made 1, 3, and 6 months later. On every study visit, body weight and body composition will be recorded and oral glucose tolerance test will be performed. Nutrient sensing test will be performed at visits 1 and 3.

Conditions

Obese; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• Change in Body Weight at 6 Months

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

  Baseline - 6 months

• Change in Body Weight at 3 Months

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

  Baseline - 3 months

• Change in Body Weight at 1 Month

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

  Baseline - 1 month

Study Arms (1)

Botox Arm

EXPERIMENTAL

Botox will be injected into duodenums of subjects via endoscopy.

Drug: Botox 200 UNT Injection

Interventions

Botox 200 UNT Injection DRUG

Botox will be injected into duodenums of subjects by endoscopy.

Also known as: Botox

Botox Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age = 18-65
• BMI ≥ 30 kg/m2
• Having established diagnosis of Type 2 diabetes or pre-diabetes

You may not qualify if:

• Patients on insulin therapy
• Endoscopy within the past 6 weeks
• Prior bariatric surgery
• Anti-obesity drugs
• Serum Creatinine \> 1.5 mg/dL
• Hepatic enzyme elevations \> 2x the upper limits of normal
• Current use of warfarin
• Abnormal ECG
• Positive pregnancy test for female subjects in the child bearing age
• Pre-existing cardiovascular disease (heart attack in the past 3 months, cardiac stenting, heart valve disorders)
• Prior surgery on the alimentary tract
• Gastroparesis
• Inflammatory bowel disease
• Liver failure

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-6602, United States

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

Early termination leading to small numbers of subjects enrolled. Technical problems due to limited enrollment leading to uninterpretable data.

Results Point of Contact

• Title: Dr Cyndya Shibao
• Organization: Vanderbilt University Medical Center

cyndya.shibao@vumc.org

6159364584

Study Officials

• Naji Abumrad, MD

  Vanderbilt University Medical Center

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: John L. Sawyers Professor and Chair; Chairman Emeritus

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 19, 2019
• Study Start: April 29, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: February 28, 2023
• Results First Posted: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)