NCT02094183

Brief Summary

Glucagon Like Peptide (GLP) -1 affects metabolic response corrected for weight change

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

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

September 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

2.6 years

First QC Date

March 17, 2014

Last Update Submit

July 4, 2014

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in hormone level corrected for weight change

    Baseline and week 52

Study Arms (2)

GLP-1

EXPERIMENTAL

GLP-1 and low calorie diet

Other: GLP-1Dietary Supplement: low calorie diet

Control

EXPERIMENTAL

low calorie diet

Dietary Supplement: low calorie diet

Interventions

GLP-1OTHER

GLP-1

GLP-1
low calorie dietDIETARY_SUPPLEMENT

low calorie diet

ControlGLP-1

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI \> 30 and \< 40 (kg/m2)
  • Healthy

You may not qualify if:

  • Other known illness
  • Medicine that affects glucose- and lipid metabolism, appetite or food intake
  • Pregnancy
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Copenhagen

Copenhagen, 2200, Denmark

Location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (3)

  • Brethvad AO, Zakariassen HL, Holt J, Lundgren JR, Jakobsen A, Hartmann B, Lehmann EW, Kissow H, Holst JJ, Madsbad S, Torekov SS, Holst B. Increased meal-induced neurotensin response predicts successful maintenance of weight loss - Data from a randomized controlled trial. Metabolism. 2023 Jun;143:155534. doi: 10.1016/j.metabol.2023.155534. Epub 2023 Mar 16.

    PMID: 36933790DERIVED

  • Akawi N, Checa A, Antonopoulos AS, Akoumianakis I, Daskalaki E, Kotanidis CP, Kondo H, Lee K, Yesilyurt D, Badi I, Polkinghorne M, Akbar N, Lundgren J, Chuaiphichai S, Choudhury R, Neubauer S, Channon KM, Torekov SS, Wheelock CE, Antoniades C. Fat-Secreted Ceramides Regulate Vascular Redox State and Influence Outcomes in Patients With Cardiovascular Disease. J Am Coll Cardiol. 2021 May 25;77(20):2494-2513. doi: 10.1016/j.jacc.2021.03.314.

    PMID: 34016263DERIVED

  • Iepsen EW, Lundgren JR, Hartmann B, Pedersen O, Hansen T, Jorgensen NR, Jensen JE, Holst JJ, Madsbad S, Torekov SS. GLP-1 Receptor Agonist Treatment Increases Bone Formation and Prevents Bone Loss in Weight-Reduced Obese Women. J Clin Endocrinol Metab. 2015 Aug;100(8):2909-17. doi: 10.1210/jc.2015-1176. Epub 2015 Jun 4.

    PMID: 26043228DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Glucagon-Like Peptide 1Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDiet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Jens Holst, DMSCi

    University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 21, 2014

Study Start

September 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

July 8, 2014

Record last verified: 2014-07

Locations

DK(2)