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Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)

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ClinicalTrials.gov Identifier: NCT02970838
Recruitment Status : Completed
First Posted : November 22, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Medicine Greifswald

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Diabetes Type 2 Weight Loss Other: Structured weight-loss program Not Applicable

Detailed Description:
Men and women with obesity and diabetes mellitus type 2 are invited to join a standardized weight-loss program (six weeks of formula diet, followed by the reintroduction of regular food with gradually increasing energy intake over nine weeks) for a duration of 15 weeks. All subjects undergo bioelectrical impedance analyses to investigate body composition and magnet resonance imaging to measure fat mass and fat fractions of abdominal organs, at three time points: first before the program, then at the end of the six weeks of formula diet and finally, at the end of the program after 15 weeks. Laboratory data are measured before and after the program.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
Study Start Date : November 2012
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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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
 Other: Structured weight-loss program

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 Name: OPTIFAST II Short Program


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c value [ Time Frame: measured at week 0 and 15 ]

Secondary Outcome Measures :
  1. Change in weight [ Time Frame: measured at week 0, 6 and 15 ]
  2. Change in body-mass-index [ Time Frame: measured at week 0, 6 and 15 ]
  3. Change in waist circumference [ Time Frame: measured at week 0, 6 and 15 ]
  4. Change in hip circumference [ Time Frame: measured at week 0, 6 and 15 ]
  5. Change in body composition [ Time Frame: measured at week 0, 6 and 15 ]
    Body composition will be assessed with bioimpedance

  6. Change in fat fractions of abdominal organs [ Time Frame: measured at week 0, 6 and 15 ]
    Fat fraction of abdominal organs will be assessed with magnet resonance imaging

  7. Change in visceral fat volume [ Time Frame: measured at week 0, 6 and 15 ]
    Visceral fat volume will be assessed with magnet resonance imaging

  8. Change in fasting glucose [ Time Frame: measured at week 0 and 15 ]
  9. Change in fasting insulin [ Time Frame: measured at week 0 and 15 ]
  10. Change in triglycerides [ Time Frame: measured at week 0, 6 and 15 ]
  11. Change in cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  12. Change in HDL cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  13. Change in LDL cholesterol [ Time Frame: measured at week 0, 6 and 15 ]
  14. Change in alanine transaminase [ Time Frame: measured at week 0, 6 and 15 ]
  15. Change in aspartate transaminase [ Time Frame: measured at week 0, 6 and 15 ]
  16. Change in gamma-glutamyl transferase [ Time Frame: measured at week 0, 6 and 15 ]
  17. Change in alkaline phosphatase [ Time Frame: measured at week 0, 6 and 15 ]
  18. Change in uric acid [ Time Frame: measured at week 0, 6 and 15 ]
  19. Change in 25-hydroxy-vitamine d3 [ Time Frame: measured at week 0 and 15 ]
  20. Change in 1,25-dihydroxy-vitamine d3 [ Time Frame: measured at week 0 and 15 ]
  21. Change in plasma calcium [ Time Frame: measured at week 0 and 15 ]
  22. Change in plasma phosphate [ Time Frame: measured at week 0 and 15 ]
  23. Change in insulin-like growth factor-1 [ Time Frame: measured at week 0 and 15 ]
  24. Change in testosterone [ Time Frame: measured at week 0 and 15 ]
  25. Change in sex hormone-binding globulin [ Time Frame: measured at week 0 and 15 ]
  26. Change in quality of life [ Time Frame: measured at week 0 and 15 ]
    Quality of life was determined using SF-12

  27. Change in sleep quality [ Time Frame: measured at week 0 and 15 ]
    Sleep quality was determined using the Pittsburgh sleep quality index

  28. Change in diet history [ Time Frame: measured at week 0 and 15 ]
    7-day food record brought in at weeks 0 and 15 will be analyzed for macronutrient intake


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970838


Locations
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Germany
University Medicine Greifswald
Greifswald, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
Investigators
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Principal Investigator: Markus M Lerch, MD Department of Medicine A, University Medicine Greifswald
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT02970838    
Other Study ID Numbers: BB62/12a
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Medicine Greifswald:
Formula diet
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Diabetes Mellitus, Type 2
Weight Loss
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Body Weight Changes