Therapy of Obesity and Diabetes Mellitus Type 2

NCT02970838 | Completed

• 1 other identifier: BB62/12a
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes Type 2; Weight Loss

Keywords

Formula diet

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c value

  measured at week 0 and 15

Secondary Outcomes (28)

• Change in weight

  measured at week 0, 6 and 15

• Change in body-mass-index

  measured at week 0, 6 and 15

• Change in waist circumference

  measured at week 0, 6 and 15

• Change in hip circumference

  measured at week 0, 6 and 15

• Change in body composition

  measured at week 0, 6 and 15

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: OPTIFAST II Short Program

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• known type 2 diabetes
• body-mass-index between 27 and 45 kg/m²

You may not qualify if:

• treatment with incretin mimetic drugs \< 3 month
• pregnancy
• immobilization
• severe heart, liver or renal failure
• dementia
• eating disorder
• alcoholism

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

University Medicine Greifswald

Greifswald, 17475, Germany

Location

Related Publications (1)

• 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.

  PMID: 31318902 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Weight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

• Markus M Lerch, MD

  Department of Medicine A, University Medicine Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 22, 2016
• Study Start: November 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)