NCT02160990

Brief Summary

The overall goal of this study was to determine the effect of exenatide on gastric emptying, satiety and satiation in obese participants. The hypothesis in this study was that exenatide retards gastric emptying in obese patients with baseline accelerated gastric emptying.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_4 obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

August 9, 2016

Completed
Last Updated

August 9, 2016

Status Verified

June 1, 2016

Enrollment Period

9 months

First QC Date

June 4, 2014

Results QC Date

February 16, 2016

Last Update Submit

June 28, 2016

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Gastric Emptying Half-time (T 1/2) of Solids

    Gastric emptying of solids half-time is defined as the time for half of the ingested solids to leave the stomach. Subjects were given a scrambled egg breakfast with toast and a glass of milk. The eggs contained a small amount of a radioactive substance. Anterior and posterior gamma camera images were obtain immediately after radiolabeled meal ingestion, every 15 minutes for the first 2 hours, then 30 minutes for the next 2 hours (total 4 hours after the radiolabeled meal).

    time frame is 30 days after the initiation of dose.

Secondary Outcomes (6)

  • Percentage of Gastric Contents Emptied at 1 Hour

    Visit 4, approximately 1 hours after radiolabeled meal was ingested

  • Change in Body Weight

    baseline, day 30

  • Satiation Expressed as Volume to Fullness

    Visit 3, approximately 30 minutes after liquid meal

  • Maximum Tolerated Volume

    Visit 3, approximately 30 minutes after liquid meal

  • Buffet Meal Intake (kcal)

    Visit 4, approximately 30 minutes after start of "all you can eat" meal

  • +1 more secondary outcomes

Study Arms (2)

Exenatide

EXPERIMENTAL

Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.

Drug: Placebo

Interventions

ExenatideDRUG

5 mcg exenatide subcutaneously twice daily for 30 days

Also known as: Byetta
Exenatide
PlaceboDRUG

placebo subcutaneously twice daily for 30 days

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obese subjects with BMI\> 30 Kg/m\^2: Otherwise healthy individuals who are not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrine (other than hyperglycemia not requiring medical therapy) and unstable psychiatric disease.
  • Women of childbearing potential will have negative pregnancy test before initiation of medication.
  • Gastric emptying (GE): Accelerated GE T1/2 \< 79 minutes or GE 1h\>35 %

You may not qualify if:

  • Type 1 or type 2 diabetes mellitus diagnosed according to American Diabetes Association criteria
  • Unstable heart disease as evidenced by ongoing angina
  • Congestive heart failure
  • Concomitant use of appetite suppressants (i.e., caffeine based or diethylpropion) or orlistat (Xenical®)
  • Uncontrolled hypertension (Blood pressure greater than 160/90 mmHg)
  • Use of anti-diabetic drugs including metformin,
  • History of nephrolithiasis,
  • Recurrent major depression, presence or history of suicidal behavior or ideation with intent to act, and current substantial depressive symptoms (Patient Health Questionnaire (PHQ-9) total score ≥10).
  • Gastroparesis
  • Inflammatory bowel disease or irritable bowel syndrome
  • Malignancy treated with chemotherapy within the past 3 years
  • History of pancreatitis
  • Renal insufficiency (eGFR less than 50 ml/min)
  • Concomitant use of monoamine oxidase inhibitors (i.e., phenelzine, selegiline), serotonergic agents, and other centrally acting appetite suppressants
  • Significant psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Scale (HADS) self-administered alcoholism screening test (SAAST, substance abuse) and the questionnaire on eating and weight patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HADS score ≥11 in any of the subscales or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Acosta A, Camilleri M, Burton D, O'Neill J, Eckert D, Carlson P, Zinsmeister AR. Exenatide in obesity with accelerated gastric emptying: a randomized, pharmacodynamics study. Physiol Rep. 2015 Nov;3(11):e12610. doi: 10.14814/phy2.12610.

    PMID: 26542264RESULT

MeSH Terms

Conditions

Obesity

Interventions

Exenatide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological Factors

Results Point of Contact

Title
Dr. Michael Camilleri
Organization
Mayo Clinic
camilleri.michael@mayo.edu
507-284-6218

Study Officials

  • Michael Camilleri, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 11, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 9, 2016

Results First Posted

August 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)