Diabetes Nutrition Algorithm - Prediabetes

Obesity Clinical Trial

— DiNA-P  

Official title:

Diabetes Nutrition Algorithm - Prediabetes (Dietary Strategies in the Prevention of Diabetes Mellitus Type 2 in a High-risk Cohort)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02609243
• Other study ID #: DiNA-P
• Status: Recruiting
• Phase: N/A
• Start date: July 2013
• Est. completion date: December 2021

Study information

• Verified date: June 2020
• Source: German Institute of Human Nutrition
• Contact: Stefan Kabisch, Dr. med.
• Phone: 030 450 514
• Email: stefan.kabisch[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

The main comparison will assess differences in metabolic outcome due to low-carb or low-fat dietary intervention in short- and long-term design.

Additionally, the role of PUFA will be assessed during long-term intervention to achieve better maintenance of metabolic improvements from the first study phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• exclusion criteria for magnetic resonance tomography

• 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

• used closed whole body scanner: claustrophobia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Dyslipidemias
• Dyslipoproteinemia
• Glucose Intolerance
• NAFLD
• Obesity
• Prediabetes
• Prediabetic State

Intervention

Behavioral:
• dietary consulting
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

Locations

Country	Name	City	State
Germany	German Institut for Human Nutrition; Department for Clinical Nutrition	Bergholz-Rehbrücke	Brandenburg
Germany	German Institute for Human Nutrition, Department for Clinical Nutrition	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
German Institute of Human Nutrition	German Diabetes Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	change in insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)	insulin resistance is calculated as follows: Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) ISIest= 10000/²v ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))	3 weeks, 6 months, 1 year, 3 years
Secondary	change in insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)	insulin resistance is calculated as follows: Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0) ISIest= 10000/²v ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))	3 weeks, 6 months, 1 year, 3 years
Secondary	change in distribution of body fat confirmed by MR-Imaging by 3 T whole body imager		3 weeks, 6 months, 1 year, 3 years