The additive effect of the appetite hormone GLP-1 (liraglutide) and exercise on maintenance of weight loss and on health parameters after a low calorie diet

Synergy effect of the appetite hormone GLP-1 (LiragluTide) and Exercise on maintenance of weight loss and health after a low calorie diet - the S-LiTE randomized trial - S-LiTE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005585-32-DK

Enrollment

222

Registered

2016-05-11

Start date

2016-06-24

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Saxenda Pharmaceutical Form: Injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656-20-2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: BMI > 32 and 18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients diagnosed with known serious chronic illness including type 1 or 2 diabetes (or a randomly measured fasting plasma glucose > 7 mmol/l) • Angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV) • Severe renal impairment (creatinine clearance (GFR) 2 hours per week.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the maintenance of weight loss and health outcomes over 1 year with GLP-1 treatment (liraglutide), exercise treatment and the combination in obese persons who has obtained at least 5 % body weight loss by low calorie diet during 8 weeks. ;Secondary Objective: Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). ;Primary end point(s): Body weight change (kg);Timepoint(s) of evaluation of this end point: week 52	—

Measure

Time frame

Main Objective: To investigate the maintenance of weight loss and health outcomes over 1 year with GLP-1 treatment (liraglutide), exercise treatment and the combination in obese persons who has obtained at least 5 % body weight loss by low calorie diet during 8 weeks. ;Secondary Objective: Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). ;Primary end point(s): Body weight change (kg);Timepoint(s) of evaluation of this end point: week 52

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Secondary

Measure	Time frame
Secondary end point(s): Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). ;Timepoint(s) of evaluation of this end point: week 52	—

Measure

Time frame

Secondary end point(s): Changes in (1) Body composition (2) Metabolic health (glucose tolerance and lipid status, waist circumference, blood pressure, Composite Metabolic syndrome Z-score) (3) Meal related appetite response (4) Peak oxygen uptake and determination of daily physical activity (5) Systemic markers of immune-metabolism and oxidation (6) Endothelial function (7) Immuno-metabolic changes in the subcutaneous adipose tissue (8) Gene expression profile of circulating inflammatory cells (9) Bone health (10) Food preferences and subjective appetite sensation (11) Faecal bacterial composition (12) Plasma metabolomics and proteomics (13) Epigenetics of spermatozoa (14) Questionnaries (SF-36, TFEQ, IPAQ, G-SES, PSQI) (13) Use of medication (n, frequency). ;Timepoint(s) of evaluation of this end point: week 52

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Countries

Denmark

Contacts

Public ContactSigne Torekov

Department of Biomedical Sciences, Faculty of Health Sciences, University of Copenhagen

torekov@sund.ku.dk004535327509

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 12, 2026