Therapy of Obesity and Diabetes Mellitus Type 2

NCT ID: NCT02970838

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-05-31

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.

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.

Conditions

Obesity; Diabetes Type 2; Weight Loss

Keywords

Formula diet

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients take part in a structured weight-loss program over 15 weeks including a fasting phase with formula diet over six weeks

Group Type: EXPERIMENTAL

Structured weight-loss program

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

OPTIFAST II Short Program

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus M Lerch, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine A, University Medicine Greifswald

Locations

University Medicine Greifswald

Greifswald, , Germany

Countries

Germany

References

Frost F, Storck LJ, Kacprowski T, Gartner S, Ruhlemann M, Bang C, Franke A, Volker U, Aghdassi AA, Steveling A, Mayerle J, Weiss FU, Homuth G, Lerch MM. A structured weight loss program increases gut microbiota phylogenetic diversity and reduces levels of Collinsella in obese type 2 diabetics: A pilot study. PLoS One. 2019 Jul 18;14(7):e0219489. doi: 10.1371/journal.pone.0219489. eCollection 2019.

Reference Type: DERIVED

PMID: 31318902 (View on PubMed)

Other Identifiers

BB62/12a

Identifier Type: -

Identifier Source: org_study_id