Hormonal Regulation of Body Weight Maintenance

January 12, 2018 updated by: Professor Joachim Spranger, Charite University, Berlin, Germany
The investigators here propose to perform a collaborative clinical research effort including a randomized controlled trial investigating the mechanisms of weight maintenance and their relation to a lifestyle intervention in children, adolescents and adults. The detailed investigation and analysis of the variability and dynamics of the endocrine circuits responding to a negative energy balance and weight loss will be accompanied and enhanced by specific clinical projects targeting peripheral and central-nervous aspects of hormonal counter-regulation after weight loss. Mechanisms of endocrine counter-regulation and potential therapeutic approaches will be studied.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Charite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 27 kg/m2 (adults)

Exclusion Criteria:

  • weight loss of more than 5kg in the last 2 months
  • pregnancy, breastfeeding

  • patients with:

    • severe heart failure
    • impaired hepatic or renal function
    • anaemia
    • disturbed coagulation (biopsies will not be taken in those subjects)
    • infection, malabsorption
    • severe hypertension
    • cancer within the last 5 years
    • eating disorders or any other psychiatric condition that would interact with the trial intervention
    • any other endocrine disorder
  • changes of smoking habits or diets within the last 3 months prior to study inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Placebo
Behavioral: placebo
no intervention, only follow up
Experimental: lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults
Behavioral: multimodal lifestyle intervention
After an initial weight loss, the weight regain will be measured during multimodal lifestyle intervention in children, adolescents and adults

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
BMI will be assessed during lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Time Frame: 21 months
BMI (kg/m2) will be analyzed after intentional weight loss in two comparable parts of a randomized controlled trial including (1) children and adolescents and (2) adults. Therefore effects of a multimodal lifestyle intervention will be compared to placebo.
21 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of leptin during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of leptin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of leptin during follow up
Time Frame: 48 months
Measurement of leptin during follow up until the 48 months
48 months
Evaluation of catecholamines during follow up
Time Frame: 48 months
Measurement of catecholamines during follow up until the 48 months
48 months
Evaluation of catecholamines during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of catecholamines at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of cortisol during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of cortisol at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of cortisol during follow up
Time Frame: 48 months
Measurement of cortisol during follow up until the 48 months
48 months
Evaluation of glucagon-like peptide 1 (GLP1) during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of GLP1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of GLP1 during follow up
Time Frame: 48 months
Measurement of GLP1 during follow up until the 48 months
48 months
Evaluation of glucose-dependent insulinotropic polypeptide (GIP) during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of GIP at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of GIP during follow up
Time Frame: 48 months
Measurement of GIP during follow up until the 48 months
48 months
Evaluation of thyroid hormones during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of thyroid hormones at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of thyroid hormones during follow up
Time Frame: 48 months
Measurement of thyroid hormones during follow up until the 48 months
48 months
Evaluation of insulin during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of insulin at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of insulin during follow up
Time Frame: 48 months
Measurement of insulin during follow up until the 48 months
48 months
Evaluation of insulin-like growth factor 1 (IGF1) during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of IGF1 at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of IGF1 during follow up
Time Frame: 48 months
Measurement of IGF1 during follow up until the 48 months
48 months
Evaluation of natriuretic peptide during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18
Measurement of natriuretic peptide at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and after additional 6 months follow up
month -3, month 0, month 12, month 18
Evaluation of natriuretic peptide during follow up
Time Frame: 48 months
Measurement of natriuretic peptide during follow up until the 48 months
48 months
Evaluation of blood pressure during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of blood pressure at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of free fatty acids (FFAs) during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of FFAs at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month -3, month 0, month 12, month 18, month 24, month 36, month 48
Evaluation of respiratory coefficient during lifestyle intervention
Time Frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of respiratory coefficient at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month -3, month 0, month 12, month 18, month 24, month 36, month 48
Measurement of messenger ribonucleic acid (mRNA) changes in adipose and skeletal muscle before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
Time Frame: month -3, month 0, month 12
Measurement of systemic and tissue specific changes in adipose tissue and skeletal muscle using RNA sequencing (counts)
month -3, month 0, month 12
Measurement of insulin sensitivity
Time Frame: month -3, month 0, month 12
Measurement of systemic and tissue specific changes in adipose and muscle insulin sensitivity using hyperinsulinemic clamp (mg•kg-1•min-1/(mU•L-1)) before (T-3), after weight loss (T0) and after as well as after 12 months randomized lifestyle intervention (or placebo)
month -3, month 0, month 12
Prediction of body weight regain
Time Frame: month 18, month 48
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on long-term course of BMI (18 and 48 months) using mathematical models
month 18, month 48
Prediction of insulin sensitivity
Time Frame: month 18, month 48
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on insulin sensitivity (18 and 48 months) using mathematical models
month 18, month 48
Prediction of energy expenditure
Time Frame: month 18, month 48
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on energy expenditure (18 and 48 months) using mathematical models
month 18, month 48
Prediction of muscle mass
Time Frame: month 18, month 48
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on muscle mass (18 and 48 months) using mathematical models
month 18, month 48
Prediction of fat mass
Time Frame: month 18, month 48
No additional measurement will be done. However, we will analyse the predictive impact of already measured parameters on fat mass (18 and 48 months) using mathematical models
month 18, month 48
BMI course after a lifestyle intervention in (1) children and adolescents and (2) adults vs. placebo
Time Frame: month 24, month 36, month 48
BMI (kg/m2) after the randomized control trial (RCT) (18 months) will be analyzed up to 48 months.
month 24, month 36, month 48
changes of fatty acids during the intervention
Time Frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Analysis of fatty acids at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month -3, month 0, month 12, month 18, month 24, month 36, month 48
changes acylcarnitines
Time Frame: month -3, month 0
Analysis of acylcarnitines at baseline and after 3 months of weight loss
month -3, month 0
changes acylcarnitines
Time Frame: month 12, month 18, month 24, month 36, month 48
Analysis of acylcarnitines after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month 12, month 18, month 24, month 36, month 48
body composition
Time Frame: month -3, month 0, month 12, month 18, month 24, month 36, month 48
Whole body fat mass (kg, %) will be measured at baseline, after 3 months of weight loss, as well as after 12 months randomized lifestyle intervention (or placebo) and and after additional 36 months follow up
month -3, month 0, month 12, month 18, month 24, month 36, month 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Charite University, Berlin, Germany

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
German Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EA2/017/09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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