Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2017-01-25
2017-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Gelesis100
Gelesis100 (2.25 g) twice daily
Gelesis100 (2.25 g)
Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
Interventions
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Gelesis100 (2.25 g)
Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
Eligibility Criteria
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Inclusion Criteria
2. Informed Consent Form signed by the subjects at the end of the GLOW study
Exclusion Criteria
2. Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
3. Subjects considering smoking cessation during the study
4. Subjects anticipating surgical intervention during the study
5. Significant intolerance to the study product during the GLOW study
6. Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is \> 8.5% (\> 69 mmol/mol)
7. Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
8. Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is \> 160 mm Hg and/or supine DBP is \> 95 mm Hg, based on the mean of two consecutive readings
9. Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
10. Anticipated requirement for use of prohibited concomitant medications
22 Years
65 Years
ALL
No
Sponsors
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Gelesis, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Hassan Heshmati, MD
Role: STUDY_DIRECTOR
Gelesis, Inc.
Locations
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Arternis Institute for Clinical Research
San Diego, California, United States
Clinical Trial Investigators
Tustin, California, United States
University of Colorado
Aurora, Colorado, United States
Westside Center for Clinical Research
Jacksonville, Florida, United States
Pennington Biomedical Research
Baton Rouge, Louisiana, United States
Boston University Medical Center
Boston, Massachusetts, United States
Cornell Weill Medical College
New York, New York, United States
Radiant Research
Cincinnati, Ohio, United States
Aventiv Research
Columbus, Ohio, United States
Geisinger Health System
Danville, Pennsylvania, United States
Texas Diabetes and Endocrinology
Round Rock, Texas, United States
Health & Care SRO
Prague, , Czechia
University of Cophenhagen
Copenhagen, , Denmark
IRCCS Policlinico San Donato
Milan, , Italy
University of Rome
Rome, , Italy
University of Navarra
Pamplona, , Spain
Countries
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Other Identifiers
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GS-100-009
Identifier Type: -
Identifier Source: org_study_id
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