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Completed

NCT Number: NCT02970838

Therapy of Obesity and Diabetes Mellitus Type 2

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medicine Greifswald

Greifswald, 17475, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured weight-loss program

Other

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: OPTIFAST II Short Program

Primary outcomes

  1. Change in HbA1c value

    Time frame: measured at week 0 and 15

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Registry information

Official study title

Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2

Acronym: TADIA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 22, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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