Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon Like Peptide 2

NCT01958775 | Completed Phase 3

• 1 other identifier: REB-07-0394
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To assess whether Glucagon like peptide 2 (GLP-2) affects lipoprotein production (study A)
2. 2.To assess whether GLP-2 affects the release of preformed chylomicrons (study B)

Conditions

Dyslipidemia

Keywords

Lipoproteins, apoB, GLP-2

Outcome Measures

Primary Outcomes (1)

• Lipoprotein production and clearance rate

  ApoB 100 and ApoB 48 production and clearance

  10 hours

Secondary Outcomes (1)

• Plasma and TRL triglyceride and TRL retinyl palmitate

  10 hours

Study Arms (2)

GLP=2

EXPERIMENTAL

active treatment with a single dose of GLP-2 (1500mcg)

Drug: GLP-2

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

GLP-2 DRUG

single subcutaneous dose of 1500mcg

Also known as: glucagon like peptide 2

GLP=2

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women, aged 18 to 60 years
• Body mass index 20 kg/m2 to 30 kg/m2
• Hemoglobin above 130g/L.
• Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test (OGTT)

You may not qualify if:

• \. Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
• \. Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr \> 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP \> 100 or systolic \> 180) or proliferative retinopathy 3. History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
• \. Any history of ischemic heart disease or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
• \. Abnormal liver or thyroid function tests 6. Current addiction to alcohol or substances of abuse as determined by the investigator.
• \. Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation 8. Taking any prescription or non-prescription medications at the time of the study 9. Having donated blood three months prior to and three months post study procedures 10. A pregnancy test will be performed 1 to 3 days prior to each study in all female research participants. Those who test positive for pregnancy will be excluded.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 1L7, Canada

Location

Related Publications (1)

• Dash S, Xiao C, Morgantini C, Connelly PW, Patterson BW, Lewis GF. Glucagon-like peptide-2 regulates release of chylomicrons from the intestine. Gastroenterology. 2014 Dec;147(6):1275-1284.e4. doi: 10.1053/j.gastro.2014.08.037. Epub 2014 Aug 28.

  PMID: 25173752 DERIVED

MeSH Terms

Conditions

Dyslipidemias

Interventions

Glucagon-Like Peptide 2

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 10, 2015

Record last verified: 2015-03

Locations

CA (1)