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Metabolic and vascular adaptations to a positive energy balance


- candidate number4262
- NTR NumberNTR1502
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2008
- Secondary IDsMEC 08/077 
- Public TitleMetabolic and vascular adaptations to a positive energy balance
- Scientific TitleMetabolic and vascular adaptations to a positive energy balance
- ACRONYMHypercaloric study
- hypothesisA positive energy balance in male subjects with a first degree relative with DM II will result in a pro-inflammatory response (MCP-1, Il 6 and TNFá) associated with inflammatory changes within adipose tissue (AT) and an increased sympathetic activity. The degree of systemic and local (AT) inflammation will be predictive for the subsequent decrease in hepatic and peripheral insulin sensitivity. The negative energy balance will restore glucose and lipid metabolism to baseline levels preceded by a decrease in inflammatory markers.
- Healt Condition(s) or Problem(s) studiedInflammation, Obesity, Diabetes Mellitus, Insulin resistance
- Inclusion criteria1. Age between 30-50
2. normal glucose tolerance (OGTT)
3. Caucasian men
4. normal weight BMI >20 and <25
- Exclusion criteria1. Age < 30- > 50 years
2. Frequent intensive exercise (>2 week) or sedentary life style
3. Any medication
4. Lipid disorders, renal insufficiency, elevated liver enzymes
5. Obesity in the past
6. BMI < 20->25 kg/m2
7. Smoking
8. Unstable weight 3 months prior to study inclusion
9. High blood pressure
10. Alcohol abuse (> 3day)
11. Participation in research during the year prior to inclusion
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-aug-2008
- planned closingdate1-aug-2010
- Target number of participants8
- InterventionsBased on the eucaloric diet in the run-in phase, a hypercaloric diet will be designed calculated as 1.4 x kcal in the eucaloric diet. The protein, fat and carbohydrate content of the diet will respectively be 16%, 30% and 54% of the caloric intake. The surplus of energy will be provided as a liquid (Nutridrink) which consists of 12 g protein, 36.8 g carbohydrates and 11.2 g fat (total 300 kcal) per 200 ml. The hypercaloric diet will be ended when study subjects reach 6%weight gain, or after 3 months if participants do not have reached the 6% weight gain.
Thereafter based on the actual REE, the subjects will consume a diet (1.0 x REE) aimed to lose the gained weight and return to baseline weight. Subjects will be monitored weekly for resting energy expenditure, physical activity, weight, body composition and dietary intake. The diet will be adjusted if the weight remains stable. The study will be ended when the participant has lost the gained weight.
- Primary outcome- Weight gain and loss
- Pro-inflammatory response in adipose tissue and in plasma after initialising a hypercaloric diet
- Change in inflammatory response after switching to hypocaloric diet
- Insulin sensitivity; Homa-IR and B-cell function
- Changes in incretine response in relation to hyper- and hypocaloric diet
- Secondary outcome- Changes in symphatic nervous activity
- Glucoregulatory hormones
- TimepointsThis study will include 8 men who will consume a hyper caloric diet until they gain sufficient amount of weight, defined as 6% of their initial body weight. We expect that the study subjects will reach this target within 2-3 months. If participants have not reached the 6% weight gain within 3 months, the hypercaloric diet will be ended also. The hypercaloric diet will directly be followed by a hypo-caloric diet to return to the baseline weight.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M. Brands
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summarySince not all obese people develop insulin resistance and the time frame between the onset of obesity and the early onset of the disturbances in lipid, glucose and endothelium metabolism is not exactly known, longitudinal studies, studying the metabolic alterations in response to a positive energy balance in humans are needed.
The present study is a prospective study to evaluate the sequence of metabolic adaptations in lean subjects, during a positive energy balance followed by a negative energy balance.
- Main changes (audit trail)
- RECORD21-okt-2008 - 19-nov-2008


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