Obesity Clinical Trial
— TADIAOfficial title:
Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
Verified date | November 2016 |
Source | University Medicine Greifswald |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
To evaluate a standardized weight-loss program as treatment option for obesity and type 2 diabetes, changes in body composition and metabolic control are investigated in obese patients with diabetes.
Status | Completed |
Enrollment | 36 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University Medicine Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c value | measured at week 0 and 15 | No | |
Secondary | Change in weight | measured at week 0, 6 and 15 | No | |
Secondary | Change in body-mass-index | measured at week 0, 6 and 15 | No | |
Secondary | Change in waist circumference | measured at week 0, 6 and 15 | No | |
Secondary | Change in hip circumference | measured at week 0, 6 and 15 | No | |
Secondary | Change in body composition | Body composition will be assessed with bioimpedance | measured at week 0, 6 and 15 | No |
Secondary | Change in fat fractions of abdominal organs | Fat fraction of abdominal organs will be assessed with magnet resonance imaging | measured at week 0, 6 and 15 | No |
Secondary | Change in visceral fat volume | Visceral fat volume will be assessed with magnet resonance imaging | measured at week 0, 6 and 15 | No |
Secondary | Change in fasting glucose | measured at week 0 and 15 | No | |
Secondary | Change in fasting insulin | measured at week 0 and 15 | No | |
Secondary | Change in triglycerides | measured at week 0, 6 and 15 | No | |
Secondary | Change in cholesterol | measured at week 0, 6 and 15 | No | |
Secondary | Change in HDL cholesterol | measured at week 0, 6 and 15 | No | |
Secondary | Change in LDL cholesterol | measured at week 0, 6 and 15 | No | |
Secondary | Change in alanine transaminase | measured at week 0, 6 and 15 | No | |
Secondary | Change in aspartate transaminase | measured at week 0, 6 and 15 | No | |
Secondary | Change in gamma-glutamyl transferase | measured at week 0, 6 and 15 | No | |
Secondary | Change in alkaline phosphatase | measured at week 0, 6 and 15 | No | |
Secondary | Change in uric acid | measured at week 0, 6 and 15 | No | |
Secondary | Change in 25-hydroxy-vitamine d3 | measured at week 0 and 15 | No | |
Secondary | Change in 1,25-dihydroxy-vitamine d3 | measured at week 0 and 15 | No | |
Secondary | Change in plasma calcium | measured at week 0 and 15 | No | |
Secondary | Change in plasma phosphate | measured at week 0 and 15 | No | |
Secondary | Change in insulin-like growth factor-1 | measured at week 0 and 15 | No | |
Secondary | Change in testosterone | measured at week 0 and 15 | No | |
Secondary | Change in sex hormone-binding globulin | measured at week 0 and 15 | No | |
Secondary | Change in quality of life | Quality of life was determined using SF-12 | measured at week 0 and 15 | No |
Secondary | Change in sleep quality | Sleep quality was determined using the Pittsburgh sleep quality index | measured at week 0 and 15 | No |
Secondary | Change in diet history | 7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake | measured at week 0 and 15 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |