Therapy of Obesity and Diabetes Mellitus Type 2 (TADIA)

November 18, 2016 updated by: University Medicine Greifswald

Evaluation of a Structured Weight-loss Program for 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.

Study Overview

Status

Completed

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Greifswald, Germany, 17475
        • University Medicine Greifswald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

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

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
Change in waist circumference
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in hip circumference
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in body composition
Time Frame: measured at week 0, 6 and 15
Body composition will be assessed with bioimpedance
measured at week 0, 6 and 15
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
measured at week 0, 6 and 15
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
Change in cholesterol
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in HDL cholesterol
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in LDL cholesterol
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in alanine transaminase
Time Frame: measured at week 0, 6 and 15
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
measured at week 0, 6 and 15
Change in uric acid
Time Frame: measured at week 0, 6 and 15
measured at week 0, 6 and 15
Change in 25-hydroxy-vitamine d3
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in 1,25-dihydroxy-vitamine d3
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in plasma calcium
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in plasma phosphate
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in insulin-like growth factor-1
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in testosterone
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in sex hormone-binding globulin
Time Frame: measured at week 0 and 15
measured at week 0 and 15
Change in quality of life
Time Frame: measured at week 0 and 15
Quality of life was determined using SF-12
measured at week 0 and 15
Change in sleep quality
Time Frame: measured at week 0 and 15
Sleep quality was determined using the Pittsburgh sleep quality index
measured at week 0 and 15
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
measured at week 0 and 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Markus M Lerch, MD, Department of Medicine A, University Medicine Greifswald

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 22, 2016

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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