- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02970838
Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)
Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Greifswald, Germany, 17475
- University Medicine Greifswald
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- known type 2 diabetes
- body-mass-index between 27 and 45 kg/m²
Exclusion Criteria:
- treatment with incretin mimetic drugs < 3 month
- pregnancy
- immobilization
- severe heart, liver or renal failure
- dementia
- eating disorder
- alcoholism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks
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During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable. Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in HbA1c value
Time Frame: measured at week 0 and 15
|
measured at week 0 and 15
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in weight
Time Frame: measured at week 0, 6 and 15
|
measured at week 0, 6 and 15
|
|
Change in body-mass-index
Time Frame: measured at week 0, 6 and 15
|
measured at week 0, 6 and 15
|
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Change in waist circumference
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
|
Change in hip circumference
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in body composition
Time Frame: measured at week 0, 6 and 15
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Body composition will be assessed with bioimpedance
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measured at week 0, 6 and 15
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Change in fat fractions of abdominal organs
Time Frame: measured at week 0, 6 and 15
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Fat fraction of abdominal organs will be assessed with magnet resonance imaging
|
measured at week 0, 6 and 15
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Change in visceral fat volume
Time Frame: measured at week 0, 6 and 15
|
Visceral fat volume will be assessed with magnet resonance imaging
|
measured at week 0, 6 and 15
|
Change in fasting glucose
Time Frame: measured at week 0 and 15
|
measured at week 0 and 15
|
|
Change in fasting insulin
Time Frame: measured at week 0 and 15
|
measured at week 0 and 15
|
|
Change in triglycerides
Time Frame: measured at week 0, 6 and 15
|
measured at week 0, 6 and 15
|
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Change in cholesterol
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in HDL cholesterol
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in LDL cholesterol
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in alanine transaminase
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
|
Change in aspartate transaminase
Time Frame: measured at week 0, 6 and 15
|
measured at week 0, 6 and 15
|
|
Change in gamma-glutamyl transferase
Time Frame: measured at week 0, 6 and 15
|
measured at week 0, 6 and 15
|
|
Change in alkaline phosphatase
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in uric acid
Time Frame: measured at week 0, 6 and 15
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measured at week 0, 6 and 15
|
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Change in 25-hydroxy-vitamine d3
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in 1,25-dihydroxy-vitamine d3
Time Frame: measured at week 0 and 15
|
measured at week 0 and 15
|
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Change in plasma calcium
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in plasma phosphate
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in insulin-like growth factor-1
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in testosterone
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in sex hormone-binding globulin
Time Frame: measured at week 0 and 15
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measured at week 0 and 15
|
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Change in quality of life
Time Frame: measured at week 0 and 15
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Quality of life was determined using SF-12
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measured at week 0 and 15
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Change in sleep quality
Time Frame: measured at week 0 and 15
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Sleep quality was determined using the Pittsburgh sleep quality index
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measured at week 0 and 15
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Change in diet history
Time Frame: measured at week 0 and 15
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7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake
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measured at week 0 and 15
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Markus M Lerch, MD, Department of Medicine A, University Medicine Greifswald
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BB62/12a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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