Clinical trial NCT02970838: Therapy of Obesity and Diabetes Mellitus Type 2
Official title: Evaluation of a Structured Weight-loss Program for Therapy of Obesity and Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Type 2
Weight Loss
Keywords: Formula diet
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c value
timeFrame: measured at week 0 and 15
Secondary outcomes:
measure: Change in weight
timeFrame: measured at week 0, 6 and 15
measure: Change in body-mass-index
timeFrame: measured at week 0, 6 and 15
measure: Change in waist circumference
timeFrame: measured at week 0, 6 and 15
measure: Change in hip circumference
timeFrame: measured at week 0, 6 and 15
measure: Change in body composition
timeFrame: measured at week 0, 6 and 15
measure: Change in fat fractions of abdominal organs
timeFrame: measured at week 0, 6 and 15
measure: Change in visceral fat volume
timeFrame: measured at week 0, 6 and 15
measure: Change in fasting glucose
timeFrame: measured at week 0 and 15
measure: Change in fasting insulin
timeFrame: measured at week 0 and 15
measure: Change in triglycerides
timeFrame: measured at week 0, 6 and 15
measure: Change in cholesterol
timeFrame: measured at week 0, 6 and 15
measure: Change in HDL cholesterol
timeFrame: measured at week 0, 6 and 15
measure: Change in LDL cholesterol
timeFrame: measured at week 0, 6 and 15
measure: Change in alanine transaminase
timeFrame: measured at week 0, 6 and 15
measure: Change in aspartate transaminase
timeFrame: measured at week 0, 6 and 15
measure: Change in gamma-glutamyl transferase
timeFrame: measured at week 0, 6 and 15
measure: Change in alkaline phosphatase
timeFrame: measured at week 0, 6 and 15
measure: Change in uric acid
timeFrame: measured at week 0, 6 and 15
measure: Change in 25-hydroxy-vitamine d3
timeFrame: measured at week 0 and 15
measure: Change in 1,25-dihydroxy-vitamine d3
timeFrame: measured at week 0 and 15
measure: Change in plasma calcium
timeFrame: measured at week 0 and 15
measure: Change in plasma phosphate
timeFrame: measured at week 0 and 15
measure: Change in insulin-like growth factor-1
timeFrame: measured at week 0 and 15
measure: Change in testosterone
timeFrame: measured at week 0 and 15
measure: Change in sex hormone-binding globulin
timeFrame: measured at week 0 and 15
measure: Change in quality of life
timeFrame: measured at week 0 and 15
measure: Change in sleep quality
timeFrame: measured at week 0 and 15
measure: Change in diet history
timeFrame: measured at week 0 and 15
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine Greifswald
Study officials:
affiliation: Department of Medicine A, University Medicine Greifswald
name: Markus M Lerch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.