Therapy of Obesity and Diabetes Mellitus Type 2

Obesity Clinical Trial

— TADIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02970838
• Other study ID #: BB62/12a
• Status: Completed
• Phase: N/A
• First received: November 1, 2016
• Last updated: November 18, 2016
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: November 2016
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

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