NCT02609243

Brief Summary

Prediabetes, defined by either impaired fasting glucose and/or impaired glucose tolerance, is a known high-risk condition predisposing to future diabetes mellitus type 2. Strategies to prevent progression from prediabetes to diabetes have been widely studied, however, without striking long-term effects of any kind of intervention (pharmacological, behavioral...). The investigators therefore investigate certain nutritional approaches concerning nutrient content and favorable food components, targeting metabolic improvement.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

7.4 years

First QC Date

March 23, 2015

Last Update Submit

June 23, 2020

Conditions

PrediabetesDiabetes Mellitus Type 2ObesityNAFLDDyslipoproteinemia

Keywords

prediabetesdiabetes mellitus type 2obesityNAFLDdyslipoproteinemia

Outcome Measures

Primary Outcomes (2)

  • change in postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))

    3 weeks, 6 months, 1 year, 3 years

  • change in hepatic fat content confirmed by proton magnetic resonance spectroscopy by 3 T MR imaging

    3 weeks, 6 months, 1 year, 3 years

Secondary Outcomes (3)

  • change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)

    3 weeks, 6 months, 1 year, 3 years

  • change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)

    3 weeks, 6 months, 1 year, 3 years

  • change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager

    3 weeks, 6 months, 1 year, 3 years

Study Arms (4)

intensive consulting, conventional diet

ACTIVE COMPARATOR

subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat ) - dietary intervention without supplement

Behavioral: dietary consulting

conventional consulting, low-carb diet

ACTIVE COMPARATOR

subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (\< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement

Behavioral: dietary consulting

conventional consulting, conventional diet

ACTIVE COMPARATOR

subjects receive 8 units of nutritional consulting, first 3 weeks of intervention phase are designed as a conventional hypocaloric low-fat diet referring to DGE guidelines (below 30 % fat), followed by 11 months of isocaloric-to-moderate-hypocaloric low-fat diet (below 30 kcal% fat) - dietary intervention without supplement

Behavioral: dietary consulting

intensive consulting, low-carb diet

ACTIVE COMPARATOR

subjects receive 16 units of nutritional consulting, first 3 weeks of intervention phase are designed as a very-low calory ketogenic (low-carb) diet (\< 40 g CH / day), following 11 months are restricted to not more than 40 % energy intake by carbohydrates under isocaloric-to-moderate-hypocaloric conditions - dietary intervention without supplement

Behavioral: dietary consulting

Interventions

dietary consultingBEHAVIORAL

dietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies

Also known as: dietary intervention without supplement
conventional consulting, conventional dietconventional consulting, low-carb dietintensive consulting, conventional dietintensive consulting, low-carb diet

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • impaired fasting glucose (IFG) fasting blood glucose 100-126 mg/dl
  • and/or
  • impaired glucose tolerance (IGT) 75 g OGTT 120 minutes: 140-200 mg/dl

You may not qualify if:

  • current pregnancy or breastfeeding
  • BMI \> 45 kg/m²
  • Diabetes mellitus Typ 1 or 2
  • serious disease e.g symptomatic coronary heart disease
  • serious symptomatic malignant disease (weight loss \> 10% within the last 6 month)
  • severe liver or kidney disease ( an increase in transaminases \> 3 times than the upper limit of the standardized range, GFR \< 50 ml/min/1,73m²)
  • systemic infection (CRP \> 1 mg/dl)
  • severe mental illness
  • drug abuse
  • treatment with steroids
  • potentially incompliant subjects
  • any kind of metal in or on the body: cardiac pacemakers prosthetic heart valves metal prosthesis magnetic implanted metallic parts contraceptive coil metal fragments/ grenade shrapnel fixed braces acupuncture needles insulin pump intraport etc. Field strength \> 3 Tesla further tattoos, permanent make-up
  • persons with limited thermosensory or heightened sensitivity to heating
  • persons where cardiovascular disease cannot be ruled out by examination
  • persons with heightened sensitivity to loud noise or diseases of the ear
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

German Institut for Human Nutrition; Department for Clinical Nutrition

Bergholz-Rehbrücke, Brandenburg, 14458, Germany

RECRUITING

German Institute for Human Nutrition, Department for Clinical Nutrition

Berlin, 12203, Germany

RECRUITING

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2ObesityNon-alcoholic Fatty Liver DiseaseDyslipidemias

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeutics

Study Officials

  • Andreas FH Pfeiffer, Prof. Dr.

    German Institute of Human Nutrition

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Kabisch, Dr. med.

CONTACT

030 450 514stefan.kabisch@charite.de

Margrit Kemper, Dr.

CONTACT

033200 88 2775margrit.kemper@dife.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director / Department for Clinical Nutrition

Study Record Dates

First Submitted

March 23, 2015

First Posted

November 20, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

DE(2)