Metabolic SyndromeNCT00774488
Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
A study testing Glucose dependent insulinotropic polypeptide (GIP) in people with Metabolic Syndrome and Obesity, run by German Institute of Human Nutrition.
Trial summary
This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity, Insulin Sensitivity
- What is being tested?
- Glucose dependent insulinotropic polypeptide (GIP)
- Type of treatment
- Injection or infusion
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI > 28
- Healthy subjects
- Normal glucose tolerance
Who cannot join
- Diabetes,IFG, IGT
- Chronical-inflammatory diseases
- Hb < 12g/dl
- Elevation in liver enzymes or creatinin concentrations
- Great weight changes within last 12 months
- Any cancer diagnosis in last 10 years
About this study
This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.
- Conditions
- Metabolic Syndrome, Obesity, Insulin Sensitivity
- Being tested
- Glucose dependent insulinotropic polypeptide (GIP)
- Keywords
- Euglycemic-hyperinsulinemic clamp, fat biopsies, microarray analysis, quantitative real time PCR, overnutrition, low grade-inflammation
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance, Overnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose dependent insulinotropic polypeptide (GIP)Other
GIP-Infusions for 4 h in a postprandial concentration
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gene expression of subcutaneous adipose tissue with microarray analysis
Measured: 3 years
Secondary outcomes (1)
Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJan 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00774488
- Sponsor's protocol ID
- GIP-Genexpression Study
- Status last verified
- Oct 2008
- First submitted
- 16 Oct 2008
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tuvia N, Pivovarova-Ramich O, Murahovschi V, Luck S, Grudziecki A, Ost AC, Kruse M, Nikiforova VJ, Osterhoff M, Gottmann P, Gogebakan O, Sticht C, Gretz N, Schupp M, Schurmann A, Rudovich N, Pfeiffer AFH, Kramer A. Insulin Directly Regulates the Circadian Clock in Adipose Tissue. Diabetes. 2021 Sep;70(9):1985-1999. doi: 10.2337/db20-0910. Epub 2021 Jul 5.
PubMed 34226282Gogebakan O, Osterhoff MA, Schuler R, Pivovarova O, Kruse M, Seltmann AC, Mosig AS, Rudovich N, Nauck M, Pfeiffer AF. GIP increases adipose tissue expression and blood levels of MCP-1 in humans and links high energy diets to inflammation: a randomised trial. Diabetologia. 2015 Aug;58(8):1759-68. doi: 10.1007/s00125-015-3618-4. Epub 2015 May 21.
PubMed 25994074Rudovich N, Pivovarova O, Gogebakan O, Sparwasser A, Doehner W, Anker SD, Arafat AM, Bergmann A, Nauck MA, Pfeiffer AF. Effect of exogenous intravenous administrations of GLP-1 and/or GIP on circulating pro-atrial natriuretic peptide in subjects with different stages of glucose tolerance. Diabetes Care. 2015 Jan;38(1):e7-8. doi: 10.2337/dc14-1452. No abstract available.
PubMed 25538323
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Glucose Dependent Insulinotropic Polypeptide (GIP) on Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT00774488
- Acronym / sponsor ID
- GIP-Genexpression Study
- Conditions
- Metabolic Syndrome, Obesity, Insulin Sensitivity
- Keywords
- Euglycemic-hyperinsulinemic clamp, fat biopsies, microarray analysis, quantitative real time PCR, overnutrition, low grade-inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jan 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical, randomized, cross-over study in obese healthy subjects aimed to analyse the acute effects of the incretin hormon Glucose Dependent Insulinotropic Polypeptide (GIP) on metabolic parameters and gene expression in subcutaneous adipose tissue.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI > 28
- Healthy subjects
- Normal glucose tolerance
Key exclusion criteria (6 listed)
- Diabetes,IFG, IGT
- Chronical-inflammatory diseases
- Hb < 12g/dl
- Elevation in liver enzymes or creatinin concentrations
- Great weight changes within last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose dependent insulinotropic polypeptide (GIP)GIP-Infusions for 4 h in a postprandial concentration | Other | – |
Primary outcome
Changes in gene expression of subcutaneous adipose tissue with microarray analysis
Time frame: 3 years
1 secondary outcome
Analysis of inflammatory marker (blood levels and gene expression), Activity of 11beta HSD and 11-beta HSD mRNA in adipose tissue, etc.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
- Derived from this study: PubMed 34226282Tuvia N, Pivovarova-Ramich O, Murahovschi V, Luck S, Grudziecki A, Ost AC, Kruse M, Nikiforova VJ, Osterhoff M, Gottmann P, Gogebakan O, Sticht C, Gretz N, Schupp M, Schurmann A, Rudovich N, Pfeiffer AFH, Kramer A. Insulin Directly Regulates the Circadian Clock in Adipose Tissue. Diabetes. 2021 Sep;70(9):1985-1999. doi: 10.2337/db20-0910. Epub 2021 Jul 5.
- Derived from this study: PubMed 25994074Gogebakan O, Osterhoff MA, Schuler R, Pivovarova O, Kruse M, Seltmann AC, Mosig AS, Rudovich N, Nauck M, Pfeiffer AF. GIP increases adipose tissue expression and blood levels of MCP-1 in humans and links high energy diets to inflammation: a randomised trial. Diabetologia. 2015 Aug;58(8):1759-68. doi: 10.1007/s00125-015-3618-4. Epub 2015 May 21.
- Derived from this study: PubMed 25538323Rudovich N, Pivovarova O, Gogebakan O, Sparwasser A, Doehner W, Anker SD, Arafat AM, Bergmann A, Nauck MA, Pfeiffer AF. Effect of exogenous intravenous administrations of GLP-1 and/or GIP on circulating pro-atrial natriuretic peptide in subjects with different stages of glucose tolerance. Diabetes Care. 2015 Jan;38(1):e7-8. doi: 10.2337/dc14-1452. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose dependent insulinotropic polypeptide (GIP) in people with Metabolic Syndrome and Obesity, run by German Institute of Human Nutrition.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gene expression of subcutaneous adipose tissue with microarray analysis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00774488, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.